FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04058749122084
·
Model: NUW-8
·
Fehling Instruments GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04058749122084
- Version / Model
- NUW-8
- Catalog Number
- NUW-8
- Company Name
- Fehling Instruments GmbH & Co. KG
- Labeler DUNS
- 315028238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-14
- Public Version
- 1
- Public Version Date
- 2022-12-22
- Public Version Status
- New
- Public Device Record Key
- 848f0ddf-5c93-4c90-91eb-cecb6eb25ae1
Device Description
CERAMO shaft with disc knife straight, 2 x 210 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32382 | Manual scalpel blade, reusable | An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04058749122084 | GS1 |
Customer Contacts
- Phone
- 800 334-5464
- [email protected]