Avitene Non-Woven Web 1010110

GUDID 10801741010474

Avitene Microfibrillar Collagen Hemostat Non-Woven Web

Davol Inc.

Collagen haemostatic agent Collagen haemostatic agent
Primary Device ID10801741010474
NIH Device Record Key3bc4855b-fffc-4fc7-b67e-3a35ae886ad9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvitene Non-Woven Web
Version Model Number1010110
Catalog Number1010110
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

Width70 Millimeter
Width70 Millimeter
Width70 Millimeter
Width70 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
GS100801741010477 [Primary]
GS110801741010474 [Package]
Contains: 00801741010477
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 Date2014-09-12

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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