FDA UDI
In Commercial Distribution
🇺🇸 United States
ISI
DI: 00810045920511
·
Model: Foam Pad - Ultra Light / Self Supporting / Free Standing
·
INSTRUMENT SPECIALISTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ISI
- Primary DI
- 00810045920511
- Version / Model
- Foam Pad - Ultra Light / Self Supporting / Free Standing
- Catalog Number
- PD-150
- Company Name
- INSTRUMENT SPECIALISTS, INC.
- Labeler DUNS
- 041517095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-23
- Public Version
- 1
- Public Version Date
- 2020-07-31
- Public Version Status
- New
- Public Device Record Key
- 5f4a5f7d-62f2-472b-9867-d811a53c474c
Device Description
4" Contoured Foam Pad - Ultra Light / Self Supporting / Free Standing
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FSE | Table, Operating-Room, Manual | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36608 | Orthopaedic operating table top | A component of a modular operating table designed as a detachable table top to support a patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted; it might be intended to provide traction, and may have x-ray transparent features. It is often intended to be used with additional patient positioners. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810045920511 | GS1 |