FDA UDI
In Commercial Distribution
🇺🇸 United States
Wenzellite
DI: 00822383531311
·
Model: FC 2000N
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wenzellite
- Primary DI
- 00822383531311
- Version / Model
- FC 2000N
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-01
- Public Version
- 1
- Public Version Date
- 2020-02-10
- Public Version Status
- New
- Public Device Record Key
- e2c86309-89e0-4f2f-8b4f-d1ff1c350cb6
Device Description
Wenzelite Seating & Positioning Product Description FirstClass SchoolChair,Sm,NewStyle,1/ea
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| INN | CHAIR, ADJUSTABLE, MECHANICAL | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31158 | Wheelchair brakes | A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This GMDN code also includes the necessary installation package. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383531311 | GS1 |