Identity
- Trade Name
- Orbitum Staple System FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- Clinical Sizer FDA UDI
- Model / Reference
- Rev A FDA UDI
- Description
- Clinical Sizer FDA UDI
Identifiers
- Catalog Number
- FO-2015 FDA UDI
- Primary DI / UDI-DI
- B565FO20150 FDA UDI
- 510(k) Number
- K173693 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical ruler, reusable
Orbitum Staple System by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173693 also covers:
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
- Orbitum Staple System — CPM Medical Consultants, LLC
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
- CPM Medical Consultants, LLC
Sources (1)
- FDA UDI 979365e3-2580-4197-b419-83e5efcca2a1 36 fields · synced Jun 8, 2026