SorbaFix Absorbable Fixation System 0113116

GUDID 10801741016704

SorbaFix Absorbable Fixation System 30 Absorbable Fasteners

Davol Inc.

Soft-tissue/mesh anchor, bioabsorbable
Primary Device ID10801741016704
NIH Device Record Key88878db3-f223-4a11-9028-b4288688dc15
Commercial Distribution StatusIn Commercial Distribution
Brand NameSorbaFix Absorbable Fixation System
Version Model Number0113116
Catalog Number0113116
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
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com

Device Dimensions

Length36 Centimeter
Length36 Centimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter
Length36 Centimeter
Outer Diameter5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741016707 [Primary]
GS110801741016704 [Package]
Contains: 00801741016707
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 Number3
Public Version Date2019-01-08
Device Publish Date2015-05-20

On-Brand Devices [SorbaFix Absorbable Fixation System]

10801741016704SorbaFix Absorbable Fixation System 30 Absorbable Fasteners
10801741016698SorbaFix Absorbable Fixation System 15 Absorbable Fasteners

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