Identity
- Trade Name
- The O.R. Company LLC FDA UDI
- Generic Name
- Hysterosonography/endometrial biopsy catheter FDA UDI
- Device Name
- "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. " FDA UDI
- Model / Reference
- UMI 4.5C-D FDA UDI
- 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. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04715309122891 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Hysterosonography/endometrial biopsy catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hysterosonography/endometrial biopsy catheter
The O.R. Company LLC by Panpac Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Panpac Medical Corporation
Sources (1)
- FDA UDI 3dd64f58-03dd-4cb4-aa8f-d8ffe174f2f2 34 fields · synced May 30, 2026