AccessGUDID - DEVICE: DAFILON (04046964564888)

GUDID

Device Identifier (DI) Information

Brand Name: DAFILON
Version or Model: B0935739
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B0935739
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046964564888
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2022
Device Count: 24
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: DAFILON BLUE 1 (4) 100CM HR37S DDP

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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
GAR	Suture, nonabsorbable, synthetic, polyamide

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: 100 Centimeter
Device Size Text, specify: Thread Material : polyamide
Device Size Text, specify: Size of Thread (USP - Others) : 1

Device Record Status

Public Device Record Key: f435dd0f-cfa1-4250-9aa0-7b5bd524314d
Public Version Date: March 17, 2022
Public Version Number: 1
DI Record Publish Date: March 09, 2022