Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Model / Reference
- 243439 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20326053104323 FDA UDI
- 510(k) Number
- K080189 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Skin marking pen, 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
MR Safe FDA UDI
Category: Skin marking pen, single-use
Regard™ by Resource Optimization & Innovation, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin marking pen, single-use.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- WriteSite® Jr. Small Preoperative Skin Marker — Aspen Surgical Products, Inc. · Class I
- NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box) — XODUS MEDICAL, INC. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- NSMKR7132 Dual Tip Skin Marker Gentian Reg & Fine Tip -PL — XODUS MEDICAL, INC. · Class I
- Richard-Allan® Utility Marker with Labels — Aspen Surgical Products, Inc. · Class I
- Richard-Allan® Fine Tip Utility Pen — Aspen Surgical Products, Inc. · Class I
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
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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
- Resource Optimization & Innovation, L.l.c.
Sources (1)
- FDA UDI c5f73817-be64-4a9e-844c-cbc910398f8a 33 fields · synced May 30, 2026