Identity
- Trade Name
- NIKOPrep FDA UDI
- Generic Name
- Electrode skin abrasion pad FDA UDI
- Device Name
- Strips for Skin Preparation (1 card of 5 pieces) FDA UDI
- Model / Reference
- 2121-5 FDA UDI
- Description
- Strips for Skin Preparation (1 card of 5 pieces) FDA UDI
Identifiers
- Catalog Number
- 2121-5 FDA UDI
- Primary DI / UDI-DI
- 10853512006766 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrode skin abrasion pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode skin abrasion pad
NIKOPrep by Nikomed Usa Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrode skin abrasion pad.
- Ambu WhiteSensor — MEDICO ELECTRODES INTERNATIONAL LIMITED · Class II
- Skintact — Leonhard Lang Co. · Class II
- Electrode Skin Prep Pads — Dynarex Corp. · Class I
- Red Dot™ — 3M COMPANY · Class II
- NIKOPrep — NIKOMED USA INC · Class II
- NIKOPrep — NIKOMED 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 II | Pending data |
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Manufacturer
- Manufacturer
- Nikomed Usa Inc
Sources (1)
- FDA UDI b0ae072a-79f6-4343-be8d-60898f0c4276 35 fields · synced Jun 1, 2026