FDA UDI
In Commercial Distribution
🇺🇸 United States
The O.R. Company LLC
DI: 04715309122891
·
Model: UMI 4.5C-D
·
PANPAC MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- The O.R. Company LLC
- Primary DI
- 04715309122891
- Version / Model
- UMI 4.5C-D
- Company Name
- PANPAC MEDICAL CORPORATION
- Labeler DUNS
- 657528899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 5
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- 3dd64f58-03dd-4cb4-aa8f-d8ffe174f2f2
Device Description
"Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff. "
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 42912 | Hysterosonography/endometrial biopsy catheter | A flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04715309122877 | GS1 | BOX | 12 | In Commercial Distribution | |
| Primary | 04715309122891 | GS1 | ||||
| Package | 04715309122907 | GS1 | Carton | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +866286472242
- [email protected]