FDA UDI
In Commercial Distribution
🇺🇸 United States
BI PHASE SYSTEM
DI: 00841036006013
·
Model: 01-0036
·
BIOMET MICROFIXATION, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BI PHASE SYSTEM
- Primary DI
- 00841036006013
- Version / Model
- 01-0036
- Catalog Number
- 01-0036
- Company Name
- BIOMET MICROFIXATION, INC
- Labeler DUNS
- 046189866
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 63007e11-b8cf-4db8-8a6f-29c2b456554a
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47677 | Craniofacial alignment rod | A surgical instrument typically used in pairs to facilitate correct cranial orientation of craniofacial implants (e.g., fixation plates being attached to jaw bones) and other devices (e.g., craniofacial distractors) during their application in craniofacial surgery. It is typically designed as a long, thin, rigid rod made of high-grade stainless steel or titanium alloy with connectors at either end for attachment to the devices being aligned; it may have a knurled mid section (to provide better grip) onto which other instruments can be locked to assist the orientation procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841036006013 | GS1 |
Customer Contacts
- Phone
- +1(904)741-4400
- [email protected]