AccessGUDID - DEVICE: DEKNATEL (14026704425645)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN026542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V-3694
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704425645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704425648

Device Description: V-PAK (G6-7101GWM8)X2

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
56303	Suture kit, non-medicated	A collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Green Braided 'silky' II POLYDEK® (Firm Pledget 1/4" x 1/8" x 1/16") AT-2, AT-2Needle/ Size- 2-0
Length: 30 Inch

Device Record Status

Public Device Record Key: ae211e0f-eb5f-4562-bed8-5b5273e29bb0
Public Version Date: August 04, 2025
Public Version Number: 5
DI Record Publish Date: March 09, 2018