AccessGUDID - DEVICE: DEKNATEL (14026704633163)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN028744
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8-5044W
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704633163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704421800

Device Description: COTTONY WHITE TAPE 3 MILLIMETER C-25 1N 18"

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?
13906	Polyester suture, non-bioabsorbable, multifilament	A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153089	000

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: 'cottony'™ II -TAPE /Needle C-25 Size-3 mm
Length: 45 Centimeter

Device Record Status

Public Device Record Key: d2567f0e-5bae-48e7-ac58-dd2fd087d3e5
Public Version Date: January 16, 2025
Public Version Number: 4
DI Record Publish Date: November 11, 2020