FDA UDI
In Commercial Distribution
🇺🇸 United States
Marina Medical
DI: 00840306826177
·
Model: AMI-6003
·
MARINA MEDICAL INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Marina Medical
- Primary DI
- 00840306826177
- Version / Model
- AMI-6003
- Catalog Number
- AMI-6003
- Company Name
- MARINA MEDICAL INSTRUMENTS, INC.
- Labeler DUNS
- 011442279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2024-05-08
- Public Version
- 1
- Public Version Date
- 2024-05-16
- Public Version Status
- New
- Public Device Record Key
- ed1b361c-ea37-4fb3-80e4-7425e042c6e1
Device Description
Uterine Manipulator/ Injector (ZAMI/Kronner 4.5) 12/bx-ACTIVE
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKF | Cannula, manipulator/injector, uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58051 | Uterine manipulator, single-use | A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00840306826160 | GS1 | ||||
| Primary | 00840306826177 | GS1 |
Customer Contacts
- Phone
- +1(954)924-4419 ext. 115
- [email protected]