Identity
- Trade Name
- AccuForm™ Cushion FDA UDI
- Generic Name
- Patient positioning foam mould kit FDA UDI
- Device Name
- Type-S™ FDA UDI
- Model / Reference
- MTACLTYPES2 FDA UDI
- Description
- Type-S™ FDA UDI
Identifiers
- Catalog Number
- MTACLTYPES2 FDA UDI
- Primary DI / UDI-DI
- 00841439114407 FDA UDI
- 510(k) Number
- K180021 FDA UDI
- FDA Product Code
- LNH FDA UDIIYE FDA UDI
- GMDN Term
- Patient positioning foam mould kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI892.5050 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient positioning foam mould kit
AccuForm™ Cushion by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning foam mould kit.
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
Cleared under the same submission
K180021 also covers:
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- AccuForm™ Cushion — Medtec LLC
- Patient Hand Grip — Medtec LLC
- Pediatric Cushion Guide — Medtec LLC
- Pediatric Registration Film — Medtec LLC
- Positioning Cushion — Medtec LLC
- ProForm™ Pediatric Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec LLC
- ProForm™ Thermoplastic — Medtec 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI a40824df-ecf2-40e1-b9a0-6d6345e240b2 37 fields · synced May 30, 2026