AccessGUDID - DEVICE: BIO-STINGER (20845854013899)

GUDID

Device Identifier (DI) Information

Brand Name: BIO-STINGER
Version or Model: V8210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V8210
Company Name: Conmed Corporation

Primary DI Number: 20845854013899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: BIO-STINGER-V BIOABSORBABLE 10 MM TINTED WITH D&C VIOLET #2, MENISCAL REPAIR DEVICE

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?
45040	Meniscus screw	A small, threaded, bioabsorbable rod intended to be used for the internal fixation of vertical lesions located in the vascularized area of the meniscus (a crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee). It is typically cannulated for guided percutaneous insertion. The device is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991715	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 10 Millimeter

Device Record Status

Public Device Record Key: 53277552-3cc3-4b27-8017-bcfce8716d97
Public Version Date: August 07, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016