Syringe Avitene 1010340

GUDID 10801741010504

Syringe Avitene Microfibrillar Collagen Hemostat

Davol Inc.

Collagen haemostatic agent Collagen haemostatic agent
Primary Device ID10801741010504
NIH Device Record Key69089a63-ab79-443c-a3cb-4a9b2cf642ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyringe Avitene
Version Model Number1010340
Catalog Number1010340
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

Weight1 Gram
Weight1 Gram

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
GS100801741010507 [Primary]
GS110801741010504 [Package]
Contains: 00801741010507
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

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00801741200779 - 3DMax™ MID Anatomical Mesh2020-08-03 3DMax™ MID Anatomical Mesh, Medium, Right, 3" x 5", 8 x 13 cm
00801741200786 - 3DMax™ MID Anatomical Mesh2020-08-03 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm
00801741200793 - 3DMax™ MID Anatomical Mesh2020-08-03 3DMax™ MID Anatomical Mesh, XL, Right, 5” x 7”, 12 x 17 cm

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