AccessGUDID - DEVICE: TAS Medical, Inc. Tissue Approximation System (00860011435907)

GUDID

Device Identifier (DI) Information

Brand Name: TAS Medical, Inc. Tissue Approximation System
Version or Model: T-4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T-4000
Company Name: TAS Medical, Inc.

Primary DI Number: 00860011435907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111249727 *Terms of Use
Previous DI: 00197644217267

Device Description: The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAR	Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220980	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
Length: 37 Centimeter
Width: 2.7 Millimeter
Height: 1.4 Micrometer

Device Record Status

Public Device Record Key: 97beb2e0-a83c-47d1-8fb2-949445792fc8
Public Version Date: January 16, 2024
Public Version Number: 1
DI Record Publish Date: January 08, 2024