PermaFix Fixation System 0113119

GUDID 10801741016711

PermaFix Fixation System 15 Fasteners

Davol Inc.

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10801741016711
NIH Device Record Key2649f4ee-6434-4b75-9cc6-752625fc30d4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePermaFix Fixation System
Version Model Number0113119
Catalog Number0113119
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
GS100801741016714 [Primary]
GS110801741016711 [Package]
Contains: 00801741016714
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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