Primo BT01
Primo BT01 is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 20 Sep 2022 (UDI-DI 00840216120624), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840216120624 | Date20 Sep 2022 | StatusListed |
Official records
- AccessGUDID record 00840216120624
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Primo
- Generic name
- Traction boot
- Model / reference
- BT01
- Primary DI / UDI-DI
- 00840216120624
- FDA product code
- FMP
- GMDN term
- Traction boot
- Device class
- Class I
- Regulation number
- 880.6450
- GUDID distribution status
- In Commercial Distribution
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