Identity
- Trade Name
- WaffleGrip FDA UDI
- Generic Name
- Operating table non-slip back pad FDA UDI
- Device Name
- WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack FDA UDI
- Model / Reference
- A302 FDA UDI
- Description
- WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack FDA UDI
Identifiers
- Catalog Number
- A302 FDA UDI
- Primary DI / UDI-DI
- 00850011479711 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Operating table non-slip back pad FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
Yes
FDA UDI
Category: Operating table non-slip back pad
WaffleGrip by Augustine Temperature Management, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table non-slip back pad.
- Prime Medical LLC — Prime Medical LLC · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- ADANTE FRICTION PAD — Mizuho Orthopedic Systems, Inc. · Class I
- PKIT HANA DISTRACTION PAD W/STRAP — Mizuho Orthopedic Systems, Inc. · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- Prime Medical LLC — Prime Medical LLC · 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
- Augustine Temperature Management, LLC
Sources (1)
- FDA UDI 7a8b17ea-eee3-4e2a-babe-048349e626ec 34 fields · synced Jun 9, 2026