- Physicians Office Resource

ACCESS 6177 10BX STERILE RF HEAD COVER
NA - 6177

Device Description

A flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
N/A

Storage Environment Temperature - Degrees Fahrenheit

135.00
-29.00

Device Sizes

Length: 120.0 Inch

Length: 120.0 Inch

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OSR

Device Name: Pacemaker/Icd/Crt Non-Implanted Components

Device Class: 3

Physical State: Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.

Definition: Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Pacemaker/ICD/CRT devices are intended to provide therapy to the heart. The non-implanted components support the implanted devices.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: KRG

Device Name: Programmer, Pacemaker

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.3700

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 10681490142653

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00681490142656

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00681490142656

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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