CapSure Permanent Fixation System 0113230

GUDID 10801741094993

CapSure Permanent Fixation System 30 Permanent Fasteners

Davol Inc.

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10801741094993
NIH Device Record Keybacfc5c1-0b6e-4aeb-ac51-1a8961e6ffdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure Permanent Fixation System
Version Model Number0113230
Catalog Number0113230
Company DUNS001191048
Company NameDavol Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Length37 Centimeter
Length37 Centimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter
Length37 Centimeter
Outer Diameter5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741094996 [Primary]
GS110801741094993 [Package]
Contains: 00801741094996
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 Date2015-06-22

On-Brand Devices [CapSure Permanent Fixation System]

10801741094993CapSure Permanent Fixation System 30 Permanent Fasteners
10801741094986CapSure Permanent Fixation System 15 Permanent Fasteners

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.