FDA UDI
In Commercial Distribution
🇺🇸 United States
Adapter, Wolf/Dyonics
DI: 10810004820736
·
Model: 5196-904
·
CLARUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Adapter, Wolf/Dyonics
- Primary DI
- 10810004820736
- Version / Model
- 5196-904
- Catalog Number
- 5196-904
- Company Name
- CLARUS MEDICAL, LLC
- Labeler DUNS
- 010316284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-23
- Public Version
- 1
- Public Version Date
- 2024-12-31
- Public Version Status
- New
- Public Device Record Key
- dcc3c900-342d-4b0d-8f82-001240b3bb10
Device Description
Adapter, Wolf/Dyonics
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
- 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
- Yes
- Sterilization Methods
- Peracetic Acid, Ethylene Oxide, Moist Heat or Steam Sterilization, Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35507 | Fibreoptic light cable | A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00810004820739 | GS1 | ||||
| Primary | 10810004820736 | GS1 |
Customer Contacts
- Phone
- 763-525-8400
- [email protected]