Identity
- Trade Name
- HNM Women Care FDA UDI
- Generic Name
- Hysterosonography/endometrial biopsy catheter FDA UDI
- Device Name
- UTERINE INJECTOR, 2mm, STERILE, BOX OF 12 FDA UDI
- Model / Reference
- HNM-36-151530 FDA UDI
- Description
- UTERINE INJECTOR, 2mm, STERILE, BOX OF 12 FDA UDI
Identifiers
- Catalog Number
- HNM-36-151530 FDA UDI
- Primary DI / UDI-DI
- 00842962103395 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
No
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
No
FDA UDI
Category: Hysterosonography/endometrial biopsy catheter
HNM Women Care by Hnm Stainless, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hysterosonography/endometrial biopsy catheter.
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- The O.R. Company LLC — PANPAC MEDICAL CORPORATION · Class II
- Rejoni Ribbed Catheter — Rejoni, Inc. · Class II
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- The O.R. Company LLC — PANPAC MEDICAL CORPORATION · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
- HNM Women Care — HNM STAINLESS, LLC. · Class II
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
- Hnm Stainless, Llc.
Sources (1)
- FDA UDI 98c03328-b36a-471e-b448-eecb00eecb05 34 fields · synced Jun 8, 2026