FDA UDI
In Commercial Distribution
🇺🇸 United States
Marina Medical
DI: 00840306821127
·
Model: 280-725
·
MARINA MEDICAL INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Marina Medical
- Primary DI
- 00840306821127
- Version / Model
- 280-725
- Catalog Number
- 280-725
- Company Name
- MARINA MEDICAL INSTRUMENTS, INC.
- Labeler DUNS
- 011442279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-04-03
- Public Version
- 3
- Public Version Date
- 2025-03-13
- Public Version Status
- Update
- Public Device Record Key
- 95a70851-4f56-473c-9155-f9dc674f72e5
Device Description
MAS!, Marina Ampler Sampler, 3mm+/-, 25/BX
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00840306837166 | GS1 | ||||
| Primary | 00840306821127 | GS1 |
Customer Contacts
- Phone
- +1(954)924-4418
- [email protected]