Identity
- Trade Name
- MAI FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Model / Reference
- 82212 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10809160361184 FDA UDI
- FDA Product Code
- NSB FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral care kit, single-use
Mai by Medical Action Industries Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral care kit, single-use.
- Halyard — Avanos Medical, Inc. · Class II
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Halyard — Avanos Medical, Inc. · Class II
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class II
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Action Industries Inc.
Sources (1)
- FDA UDI c4a83afd-f79b-43b4-965a-48ce5e41507d 33 fields · synced May 30, 2026