DISPOSABLE CURVED APPLICATOR

DISPOSABLE CURVED APPLICATOR
NA - ADS201815

A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

• 10 Centimeter x 10 Gauge

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KYZ

Device Name: Syringe, Irrigating (Non Dental)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.6960

Third Party Flag: N

Medical Specialty: HO

Device Id: 20085412624826

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00085412624822

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 00085412624822

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

Device Id: 50085412624827

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20085412624826

Package Quantity: 24

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA