Identity
- Trade Name
- Summit X-ray Collimator FDA UDI
- Generic Name
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
- Device Name
- Collimator, manual, Radiographic (892-1610) FDA UDI
- Model / Reference
- D800 FDA UDI
- Description
- Collimator, manual, Radiographic (892-1610) FDA UDI
Identifiers
- Catalog Number
- D800 FDA UDI
- Primary DI / UDI-DI
- B307D8000 FDA UDI
- 510(k) Number
- K874687 FDA UDI
- FDA Product Code
- IZX FDA UDI
- GMDN Term
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1610 FDA UDI
- Commercial Distribution
- Not 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
No
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
Summit X-ray Collimator by Summit Industries, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Summit Industries, Llc
Sources (1)
- FDA UDI 2906f387-ea67-470f-bc94-f374290310dc 38 fields · synced May 30, 2026