Identity
- Trade Name
- LEAP Collimator FDA UDI
- Generic Name
- Multi-hole nuclear medicine system collimator, low-energy FDA UDI
- Model / Reference
- LEAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850816007126 FDA UDI
- FDA Product Code
- IYX FDA UDI
- GMDN Term
- Multi-hole nuclear medicine system collimator, low-energy FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1100 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
Yes
FDA UDI
Category: Multi-hole nuclear medicine system collimator, low-energy
LEAP Collimator by Digirad Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-hole nuclear medicine system collimator, low-energy.
- High Energy Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Medium Energy Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Fan Beam Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- LEAP Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Low Energy High Res Collimator — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Pinhole with 4 mm aperture — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Collimator Asm Smart Zoom — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Fan Beam Collimator Asm Symbia — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Digirad Corp.
Sources (1)
- FDA UDI ce618765-3b8d-45fa-a1c9-e1d5dd07c596 33 fields · synced May 30, 2026