FDA UDI
In Commercial Distribution
🇺🇸 United States
ShroudGuard™
DI: 00811836030754
·
Model: 37314
·
Dan Allen Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ShroudGuard™
- Primary DI
- 00811836030754
- Version / Model
- 37314
- Company Name
- Dan Allen Surgical LLC
- Labeler DUNS
- 040876183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-25
- Public Version
- 1
- Public Version Date
- 2024-07-03
- Public Version Status
- New
- Public Device Record Key
- 330e6dab-a811-4c66-b55b-04755643d897
Device Description
ShroudGuard Surround 5085+ OR Table Pedestal Protector for STERIS® 5085, 5095
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65222 | Operating table pedestal protector | A device in the form of a fence/surround intended to protect the pedestal/cladding of an operating table from direct physical damage. It is a multi-piece shield/guard which clips together around the perimeter of the base of the pedestal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811836030754 | GS1 |