Avitene Non-Woven Web 1010090

GUDID 10801741010467

Avitene Microfibrillar Collagen Hemostat Non-Woven Web

Davol Inc.

Collagen haemostatic agent Collagen haemostatic agent
Primary Device ID10801741010467
NIH Device Record Key67ce91a7-a684-434f-8fc9-b9ef768e47a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvitene Non-Woven Web
Version Model Number1010090
Catalog Number1010090
Company DUNS001191048
Company NameDavol Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)562-0027
Emailmedical.services@crbard.com
Phone+1(800)562-0027
Emailmedical.services@crbard.com

Device Dimensions

Width35 Millimeter
Width35 Millimeter
Width35 Millimeter
Width35 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741010460 [Primary]
GS110801741010467 [Package]
Contains: 00801741010460
Package: CA [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMFAgent, absorbable hemostatic, collagen based

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-10

On-Brand Devices [Avitene Non-Woven Web]

10801741010474Avitene Microfibrillar Collagen Hemostat Non-Woven Web
10801741010467Avitene Microfibrillar Collagen Hemostat Non-Woven Web
10801741010450Avitene Microfibrillar Collagen Hemostat Non-Woven Web

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