FDA UDI
In Commercial Distribution
🇺🇸 United States
Marina Medical
DI: 00840306824166
·
Model: 210-240
·
MARINA MEDICAL INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Marina Medical
- Primary DI
- 00840306824166
- Version / Model
- 210-240
- Catalog Number
- 210-240
- Company Name
- MARINA MEDICAL INSTRUMENTS, INC.
- Labeler DUNS
- 011442279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-29
- Public Version
- 2
- Public Version Date
- 2025-01-17
- Public Version Status
- Update
- Public Device Record Key
- a8d9775e-c4b8-455a-9b4a-6d15ba9c7382
Device Description
Pratt Rectal Probe, 19.7cm shaft
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXX | PROBE, RECTAL, NON-POWERED | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62025 | Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable | A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840306824166 | GS1 |
Customer Contacts
- Phone
- +1(954)924-4418
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 19.7 | Centimeter |