FDA UDI
In Commercial Distribution
🇺🇸 United States
Bilateral BMA Kit
DI: 00880304640962
·
Model: 800-0710
·
Biomet Biologics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bilateral BMA Kit
- Primary DI
- 00880304640962
- Version / Model
- 800-0710
- Catalog Number
- 800-0710
- Company Name
- Biomet Biologics, LLC
- Labeler DUNS
- 802003074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-30
- Public Version
- 1
- Public Version Date
- 2021-11-08
- Public Version Status
- New
- Public Device Record Key
- 8b9fc76c-567a-4ff9-97e3-6713e904811f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWE | Bone marrow collection/transfusion kit | Unknown | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33984 | Bone marrow collection/transfusion set | A sterile collection of instruments, pharmaceuticals, and other items intended for use in combination to collect and/or deliver bone marrow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304640962 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]