AccessGUDID - DEVICE: NA (10888551007931)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: COOCTI-512N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: COOCTI-512N, COOCTI-512N-5
Company Name: STERILMED, INC.

Primary DI Number: 10888551007931
Issuing Agency: GS1
Commercial Distribution End Date: July 16, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: Carter-Thomason CloseSure System

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":	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?
61823	Suturing unit, reprocessed	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 previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NLM	LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133414	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 9183a21d-9454-4ae9-8837-e200b294bf71
Public Version Date: July 17, 2025
Public Version Number: 9
DI Record Publish Date: September 22, 2016