FDA Registration
Active
🇫🇷 France
OTIS-F AO diam. 6.5 mm tap, Catalog Number EVO90T8086
Reg #: 3004549189
·
FEI: 3004051158
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SCIENCE & BIO MATERIALS, S.B.M. SAS
- Registration Number
- 3004549189
- FEI Number
- 3004051158
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZI DU MONGE
- City
- LOURDES Hautes-Pyrenees
- Country
- FR
Owner / Operator
- Firm Name
- SCIENCE & BIO MATERIALS
- Operator Number
- 9063735
- Address
- S.B.M. SAS - ZI DU MONGE, --
- City
- Lourdes
- State
- Hautes-Pyrenees
- Postal Code
- 65100
- Country
- FR
- Correspondent
- Anne - COSPIN
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2019-12-05 |
Proprietary Names
OTIS-F AO diam. 6.5 mm tap, Catalog Number EVO90T8086
OTIS-F AO diam.4.5 mm tap, Catalog Number EVO900T868
LIGAFIX ratchet tap rod Diameter 7-8 mm, Catalog Number LIG9000319
ComposiTCP 4.5 mm Suture Anchor Punch Tap, Catalog Number 110026111
ComposiTCP 5.5 mm and 6.5 mm Suture Anchor Punch Tap, Catalog Number 110026112
LIGAFIX White tap for diam. 7 mm screws, Catalog Number LIG9000169
LIGAFIX Black tap for diam. 8, 9 & 10 mm screws, Catalog Number LIG9000093
FIXIT & ecoFIX 5.5 mm and 6.5mm Suture Anchor Punch Tap, Catalog Number EPA9000241
FIXIT & ecoFIX 4.5 mm Suture Anchor Punch Tap, Catalog Number EPA9000240
LIGAFIX ratchet tap rod Diameter 9-10-11 mm, Catalog Number LIG9000320
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device