AccessGUDID - DEVICE: Meniscus Suture - OUT IN (07899258658292)

GUDID

Device Identifier (DI) Information

Brand Name: Meniscus Suture - OUT IN
Version or Model: Meniscus Suture - OUT IN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 354-100-050
Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA

Primary DI Number: 07899258658292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 900865213 *Terms of Use

Device Description: Meniscus Suture - Out in 424 x 30 x 25mm

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?
66530	Meniscus suture anchor	A non-bioabsorbable, implantable device designed for suture-based meniscal tear repair and/or meniscus allograft stabilization. It is a small, bar-shaped, synthetic polymer device with holes for passing a suture, which is typically included. It is implanted using dedicated disposable arthroscopic instruments, which may be provided with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: dff6bcfa-1888-4e19-9aca-216970bb8eaf
Public Version Date: January 26, 2024
Public Version Number: 1
DI Record Publish Date: January 18, 2024