FDA UDI
In Commercial Distribution
🇺🇸 United States
TrenGuard™
DI: 00811836030440
·
Model: 54612
·
Dan Allen Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- TrenGuard™
- Primary DI
- 00811836030440
- Version / Model
- 54612
- Company Name
- Dan Allen Surgical LLC
- Labeler DUNS
- 040876183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 1
- Public Version Date
- 2024-11-19
- Public Version Status
- New
- Public Device Record Key
- b7f33640-3a89-4cf6-bd20-3191cf6358c9
Device Description
TrenGuard 450 Solo Wedge Packs - 12 Each disposable packs (each pack includes one wedge bolster)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 62650 | Operating table torso positioner | A preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811836030440 | GS1 | ||||
| Unit of Use | 00811836030884 | GS1 |