AccessGUDID - DEVICE: GORE SEAMGUARD Bioabsorbable Staple Line Reinforce (00733132627004)

GUDID

Device Identifier (DI) Information

Brand Name: GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
Version or Model: BSGEC60AC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BSGEC60AC
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132627004
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: BSGEC60 Anvil & Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043056	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c967c304-2af4-446e-94be-a966d7d105af
Public Version Date: December 13, 2022
Public Version Number: 7
DI Record Publish Date: September 11, 2017