AccessGUDID - DEVICE: TenSURE (10840143904455)

GUDID

Device Identifier (DI) Information

Brand Name: TenSURE
Version or Model: 80-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-0017-02
Company Name: ATRICURE, INC.

Primary DI Number: 10840143904455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use
Previous DI: 10840143901911

Device Description: TenSURE Suture Tightener

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?
47462	Suture knot-tying device	A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZT	Cutter, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 40dc9f5d-1416-4ada-ae6a-2d490f128655
Public Version Date: August 06, 2021
Public Version Number: 1
DI Record Publish Date: July 29, 2021