Identity
- Trade Name
- IntraSpin FDA UDI
- Generic Name
- Haematological concentrate system FDA UDI
- Device Name
- IntraSpin Power Cord, 220v FDA UDI
- Model / Reference
- BPOWER220 FDA UDI
- Description
- IntraSpin Power Cord, 220v FDA UDI
Identifiers
- Catalog Number
- BPOWER220 FDA UDI
- Primary DI / UDI-DI
- D742BPOWER2201 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological concentrate system
IntraSpin by Intra-Lock International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK120048 also covers:
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Intra-Lock International
Sources (1)
- FDA UDI 82f2b536-1ff4-4e53-b9ed-e656c629d831 36 fields · synced May 30, 2026