FDA UDI
In Commercial Distribution
🇺🇸 United States
Schaerer Medical USA
DI: 10810101300377
·
Model: 73016
·
Schaerer Medical Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Schaerer Medical USA
- Primary DI
- 10810101300377
- Version / Model
- 73016
- Catalog Number
- 73016
- Company Name
- Schaerer Medical Usa, Inc.
- Labeler DUNS
- 092820703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- 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
- f2582c83-c4c1-4d2f-a677-3c4aa0211be1
Device Description
DRAPERY ROD ASSEMBLY
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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35501 | Anaesthesia screen | A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810101300370 | GS1 | ||||
| Primary | 10810101300377 | GS1 |
Customer Contacts
- Phone
- 1-800-755-6381
- [email protected]