AccessGUDID - DEVICE: DEKNATEL (34026704428626)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN027362
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XS-766
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704428626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704428625

Device Description: SLK BK BR 3-0 T-4 1N 30

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:	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?
13910	Silk suture	A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAP	SUTURE, NONABSORBABLE, SILK

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: none

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: SILK /Needle T-4 Size-3-0
Length: 75 Centimeter

Device Record Status

Public Device Record Key: 106878ec-d5cc-4546-8506-3788e1538b8d
Public Version Date: January 10, 2024
Public Version Number: 7
DI Record Publish Date: March 24, 2017