FDA UDI
In Commercial Distribution
🇺🇸 United States
RZ Medizintechnik GmbH
DI: 04049197530965
·
Model: 290-195-330
·
RZ-Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RZ Medizintechnik GmbH
- Primary DI
- 04049197530965
- Version / Model
- 290-195-330
- Catalog Number
- 290-195-330
- Company Name
- RZ-Medizintechnik GmbH
- Labeler DUNS
- 312953227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-28
- Public Version
- 1
- Public Version Date
- 2024-07-08
- Public Version Status
- New
- Public Device Record Key
- 1313f3d4-bb03-42c5-a065-d47a69ce9ade
Device Description
Garrett Vascular Dilator, malleable, D: 3,0mm 350mm
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
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAX | BOUGIE, UROLOGICAL | Gastroenterology, Urology | 876.5520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11268 | Vascular dilator, reusable | A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049197530965 | GS1 |
Customer Contacts
- Phone
- +49746294700
- [email protected]