Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
- Model / Reference
- 243456 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20326053104330 FDA UDI
- 510(k) Number
- K080189 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sharp surgical instrument counting tray/pad, single-use
Regard™ by Resource Optimization & Innovation, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080189 also covers:
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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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
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI 8e684e0b-939c-4ced-8674-05dac17054b4 33 fields · synced May 30, 2026