AccessGUDID - DEVICE: T-Line Hernia Mesh (00850002394047)

GUDID

Device Identifier (DI) Information

Brand Name: T-Line Hernia Mesh
Version or Model: TL3007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TL3007
Company Name: Deep Blue Medical Advances, Inc.

Primary DI Number: 00850002394047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079752359 *Terms of Use

Device Description: T-Line Hernia Mesh, 29cm x 5.5cm

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?
65117	Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial	A flat or three-dimensional (3-D), woven/knitted material made of non-bioabsorbable synthetic polymer(s) intended for multiple defective tissue repair applications at different anatomical zones (e.g., thoracic, abdominal) that includes an extra-abdominal application(s); it does not include an antimicrobial agent(s), but may include a mesh coating (e.g., titanium, omega 3, monocryl, hyaluronate) intended to supplement mesh performance. It may also be used as a scaffold for tissue regeneration. Disposable devices associated with implantation may be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193144	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: 8c24fc77-a2be-4485-97e3-9e785269b544
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 30, 2020