TAS Medical, Inc. Tissue Approximation System T-4000

GUDID 00197644217267

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.

TAS Medical, Inc.

Nylon suture, non-bioabsorbable, monofilament

Primary Device ID	00197644217267
NIH Device Record Key	446b9164-089f-4fde-b50e-76a9864de386
Commercial Distribution Status	In Commercial Distribution
Brand Name	TAS Medical, Inc. Tissue Approximation System
Version Model Number	T-4000
Catalog Number	T-4000
Company DUNS	111249727
Company Name	TAS Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer
Length	37 Centimeter
Width	2.7 Millimeter
Height	1.4 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197644217267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K220980

FDA Product Code

GAR	Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-14
Device Publish Date	2023-11-06

On-Brand Devices [TAS Medical, Inc. Tissue Approximation System]

00197644217267	The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to
00197644927241	The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to
00860011435921	The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to