FDA UDI
In Commercial Distribution
🇺🇸 United States
Schaerer Medical USA
DI: 00810101300004
·
Model: 10900
·
Schaerer Medical Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Schaerer Medical USA
- Primary DI
- 00810101300004
- Version / Model
- 10900
- Catalog Number
- 10900
- Company Name
- Schaerer Medical Usa, Inc.
- Labeler DUNS
- 092820703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-16
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- 7b5cbae2-05f1-45da-a5da-d9b53a5ba4d9
Device Description
CHICK LP
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
- 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 |
|---|---|---|---|---|
| JEB | Table, Surgical With Orthopedic Accessories, Manual | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38528 | Orthopaedic operating table, hydraulic | A mobile table powered by manually-operated hydraulic mechanisms designed to support a patient and to provide traction for the limb(s) of the patient (upper or lower extremity) during orthopaedic surgical procedures. Its surface consists of sections that can be height-adjusted in relation to the section supporting the patient's trunk, and the sections that initially support the legs which are lowered once the patient has been placed in traction. Broken bones can be drawn apart, repositioned, and set to the correct position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810101300004 | GS1 |