PermaFix Fixation System 0113120

GUDID 10801741016728

PermaFix Fixation System 30 Fasteners

Davol Inc.

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10801741016728
NIH Device Record Keydf38826a-4d87-4b18-961e-e38fa65a0489
Commercial Distribution StatusIn Commercial Distribution
Brand NamePermaFix Fixation System
Version Model Number0113120
Catalog Number0113120
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

Length36 Centimeter
Length36 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741016721 [Primary]
GS110801741016728 [Package]
Contains: 00801741016721
Package: CA [5 Units]
In Commercial Distribution

FDA Product Code

GDWSTAPLE, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2015-05-20

On-Brand Devices [PermaFix Fixation System]

10801741016728PermaFix Fixation System 30 Fasteners
10801741016711PermaFix Fixation System 15 Fasteners

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