FDA UDI
In Commercial Distribution
🇺🇸 United States
ACL CROSSPIN
DI: 00880304421301
·
Model: 905855
·
Biomet Sports Medicine, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACL CROSSPIN
- Primary DI
- 00880304421301
- Version / Model
- 905855
- Catalog Number
- 905855
- Company Name
- Biomet Sports Medicine, LLC
- Labeler DUNS
- 627100159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 1fcf827a-3cc2-47d5-83e5-ee015d3ad26e
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 |
|---|---|---|---|---|
| JDR | STAPLE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45037 | Orthopaedic bone pin, bioabsorbable | A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304421301 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 50 MM 4MM Ø |