TAS Medical, Inc. Tissue Approximation System T-5000

GUDID 00860011435921

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 ID00860011435921
NIH Device Record Key67f35b0f-a660-4ba7-95bb-e0ba7450918e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAS Medical, Inc. Tissue Approximation System
Version Model NumberT-5000
Catalog NumberT-5000
Company DUNS111249727
Company NameTAS Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter
Length37 Centimeter
Width2.7 Millimeter
Height1.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011435921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-17
Device Publish Date2024-09-09

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

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

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