AccessGUDID - DEVICE: DEKNATEL (14026704425027)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN026416
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V-2535
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704425027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704425020

Device Description: V-PAK ASST'D SUTURES X11

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":	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?
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
Length: 60 Inch
Device Size Text, specify: Black Braided SILK Needle/ Size- 2

Device Record Status

Public Device Record Key: f02cff15-57a9-4e3e-a974-37e7e3527b0e
Public Version Date: January 16, 2025
Public Version Number: 8
DI Record Publish Date: March 24, 2017