FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIUM
DI: 10886982309570
·
Model: 05.001.604
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UNIUM
- Primary DI
- 10886982309570
- Version / Model
- 05.001.604
- Catalog Number
- 05001604
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-10
- Public Version
- 1
- Public Version Date
- 2021-09-20
- Public Version Status
- New
- Public Device Record Key
- d79350b6-8b9f-4822-819f-1068c7349dbb
Device Description
UNIUM(TM) ADAPTER FOR UBC II
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOQ | BATTERY, REPLACEMENT, RECHARGEABLE | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60447 | Surgical power tool maintenance adaptor | A device intended to connect a surgical power tool (e.g., pneumatically or electrically driven motors, turbines, or attachments) to a maintenance device (i.e., maintenance unit or lubricant container) during maintenance/lubrication of the surgical power tool. It is typically a metal attachment designed to connect a specific type of tool and maintenance device together. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07611819654204 | GS1 | ||||
| Primary | 10886982309570 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]