AccessGUDID - DEVICE: DEKNATEL (14026704912787)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN927836
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FD-4522M2K
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704912787
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704592159

Device Description: DEKLENE MAXX BLUE MONOFILAMENT 5-0 AT-6 2N 24" X2 PFS

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?
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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
GAW	Suture, nonabsorbable, synthetic, polypropylene

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Centimeter
Device Size Text, specify: DEKLENE® MAXX™ /Needle AT-6, AT-6 Size-5-0

Device Record Status

Public Device Record Key: c278c8c7-158c-4407-8bea-81cb563236e1
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023