FDA UDI
In Commercial Distribution
🇺🇸 United States
2.0 LACTOSORB SYSTEM
DI: 00841036055097
·
Model: 915-2307
·
BIOMET MICROFIXATION, INC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 2.0 LACTOSORB SYSTEM
- Primary DI
- 00841036055097
- Version / Model
- 915-2307
- Catalog Number
- 915-2307
- Company Name
- BIOMET MICROFIXATION, INC
- Labeler DUNS
- 046189866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-11
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- bae8ae92-ae6d-45ab-adfd-7bbf2f77a5aa
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 |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| JEY | PLATE, BONE | Dental | 872.4760 | 2 |
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46637 | Craniofacial bone screw, bioabsorbable | A small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841036055097 | GS1 |
Customer Contacts
- Phone
- +1(904)741-4400
- [email protected]