FDA UDI
In Commercial Distribution
🇺🇸 United States
Marina Medical
DI: 00840306804663
·
Model: 190-324
·
MARINA MEDICAL INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Marina Medical
- Primary DI
- 00840306804663
- Version / Model
- 190-324
- Catalog Number
- 190-324
- Company Name
- MARINA MEDICAL INSTRUMENTS, INC.
- Labeler DUNS
- 011442279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 4
- Public Version Date
- 2025-03-10
- Public Version Status
- Update
- Public Device Record Key
- 863a0146-6f14-4df6-bab4-44b98cbc61b4
Device Description
Hartman Alligator Forceps, Micro Jaw, 8.5cm
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
- Yes
- 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 |
|---|---|---|---|---|
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65512 | Direct-percutaneous-access endoscopic tissue manipulation forceps | A rigid, hand-held, manual surgical instrument with a sharp tip designed for direct penetration of skin and soft tissues to access an endoscopic surgical site (e.g., laparoscopic), without need of a traditional insertion conduit, where it is intended to grasp and manipulate tissues. It has proximal controls (e.g., scissors-like handles), a rigid long thin shaft which terminates with a needle tip, and distal grasping jaws. It is intended to be used under direct visualization with an endoscope but is not intended to be inserted through an endoscopic port, cannula, or working channel; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840306804663 | GS1 |
Customer Contacts
- Phone
- +1(954)924-4418 ext. 115
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.5 | Centimeter |