AccessGUDID - DEVICE: Stratafix Spiral (10705031228047)

GUDID

Device Identifier (DI) Information

Brand Name: Stratafix Spiral
Version or Model: SXMD1B100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Surgical Specialties México, S. de R.L. de C.V.

Primary DI Number: 10705031228047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 812762226 *Terms of Use

Device Description: PS-1 2-0 MONODERM 30CM

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?
60480	Barbed polyester suture, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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
Device Size Text, specify: 2-0 USP

Device Record Status

Public Device Record Key: 97a3c3ed-98b1-40f8-a09b-039886b7ad1c
Public Version Date: December 25, 2024
Public Version Number: 6
DI Record Publish Date: October 22, 2015