Identity
- Trade Name
- Block low CF ExaFix™ FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Carbon fiber elevation block, fit for ExaFix, low FDA UDI
- Model / Reference
- CFBL FDA UDI
- Description
- Carbon fiber elevation block, fit for ExaFix, low FDA UDI
Identifiers
- Catalog Number
- 110510 FDA UDI
- Primary DI / UDI-DI
- 08719425700922 FDA UDI
- 510(k) Number
- K142420 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Indexed-immobilization patient positioning system
Block low CF ExaFix™ by Macromedics B.v. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indexed-immobilization patient positioning system.
- QUANTUM™ CT Overlay — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- IPPS™ Overlay — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Arm Support, Single Adjust, Elekta Compatible — Aktina Corp. · Class II
Cleared under the same submission
K142420 also covers:
- Adaptor MaxSupport™ TO — MACROMEDICS B.V.
- Adaptor MaxSupport™ TS — MACROMEDICS B.V.
- Block high CF ExaFix™ — MACROMEDICS B.V.
- BreastBoardLX™ — MACROMEDICS B.V.
- CouchStrip CSMF — MACROMEDICS B.V.
- CouchStrip CSMFGF — MACROMEDICS B.V.
- CouchStrip CSNF — MACROMEDICS B.V.
- CouchStrip CSNFCF — MACROMEDICS B.V.
- CouchStrip CSWF — MACROMEDICS B.V.
- DSCP™ KS indexstrip — MACROMEDICS B.V.
- DSPS® Cradle-MEXF H MR — MACROMEDICS B.V.
- DSPS® Cradle-O H MR — MACROMEDICS B.V.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (1)
- FDA UDI 76bc9614-9383-43d9-ac03-3f276cde3ea3 35 fields · synced May 30, 2026