- Physicians Office Resource

Malleable Extended Applicator
Vitagel - 2113-0002

Device Description

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.

Environmental Conditions

Special Storage Condition, Specify

Dry and Ambient

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LMF

Device Name: Agent, Absorbable Hemostatic, Collagen Based

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.4490

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 30808232000802

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00808232000801

Package Quantity: 5

Package Discontinue Date: 6/30/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: pack

Device Id: 00808232000801

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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