TAPES

Basic Information

• Brand Name: TAPES
• Primary DI: 05425029282094
• Version / Model: TAPES
• Company Name: Endo Tools Therapeutics
• Labeler DUNS: 400000750
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-19
• Public Version: 2
• Public Version Date: 2022-08-25
• Public Version Status: Update
• Public Device Record Key: 74cfbcc9-1961-46ea-b1be-3e26d7375414

Device Description

TAPES primary packaging (x1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05425029282698	GS1	secondary packaging	6	In Commercial Distribution
Primary	05425029282094	GS1
Package	05425029282391	GS1	Tertiary packaging	12	In Commercial Distribution
Package	05425029282995	GS1	Pallet	288	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K211309	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius