FDA UDI
In Commercial Distribution
🇺🇸 United States
WaffleGrip
DI: 00850011479711
·
Model: A302
·
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WaffleGrip
- Primary DI
- 00850011479711
- Version / Model
- A302
- Catalog Number
- A302
- Company Name
- AUGUSTINE TEMPERATURE MANAGEMENT LLC
- Labeler DUNS
- 965879187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-12
- Public Version
- 1
- Public Version Date
- 2024-09-20
- Public Version Status
- New
- Public Device Record Key
- 7a8b17ea-eee3-4e2a-babe-048349e626ec
Device Description
WaffleGrip Trendelenburg Positioning Kit for Electrosurgery, 10 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62789 | Operating table non-slip back pad | A non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011479711 | GS1 |