AccessGUDID - DEVICE: Syneture (10884521161597)

GUDID

Device Identifier (DI) Information

Brand Name: Syneture
Version or Model: US1596
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: US1596
Company Name: Covidien LP

Primary DI Number: 10884521161597
Issuing Agency: GS1
Commercial Distribution End Date: October 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Custom Suture Pack,(4) CN-825;(2) GLS-322;(2) GS-832;(2) GS-833;(2) S-303;(2) S-304;(3) S-305;(2) S-316;(2) SS-677;(2) VP-521-X;(4) VP-556-X;(4) VP-706-X

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:	Yes
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?
13892	Suture kit, medicated	A collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVN	Suture kit

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
Handling Environment Temperature: less than 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b72eedd-b2b4-4120-9eeb-8514a4ce8397
Public Version Date: June 13, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016