AccessGUDID - DEVICE: DEKNATEL (34026704555193)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN026621
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: V-3790
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704555193
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704555192

Device Description: V-PAK (B7-7040)X5 (B7-7040W)X5

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 TEVDEK® II (Soft Pledget 1/4" x 1/8" x 1/16") T-5, T-5Needle/ Size- 0
Length: 30 Inch

Device Record Status

Public Device Record Key: 299d5c93-21ee-45c8-8a11-fd38fbd12152
Public Version Date: August 04, 2025
Public Version Number: 5
DI Record Publish Date: March 09, 2018