FDA UDI
In Commercial Distribution
🇺🇸 United States
BIO-STINGER
DI: 20845854014353
·
Model: V8213
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIO-STINGER
- Primary DI
- 20845854014353
- Version / Model
- V8213
- Catalog Number
- V8213
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- a66cb06e-ee6a-48ac-8b8a-83efafb09d5b
Device Description
BIO-STINGER-V BIOABSORBABLE 13 MM TINTED WITH D&C VIOLET #2, MENISCAL REPAIR DEVICE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20845854014353 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991715 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 13 | Millimeter | |
| Outer Diameter | 13 | Millimeter |