Identity
- Trade Name
- Batrik H/S Catheter TM 7F FDA UDI
- Generic Name
- Intrauterine imaging medium catheter FDA UDI
- Device Name
- H/S Catheters are latex free medical devices used to inject contrast media or saline into the uterus through the fluid lumen of the tube. This devices consist of a flexible (size 7FR) tube with a balloon at the distal end. Intended to be used during sonohysterography and Hysterosalpingography procedures. FDA UDI
- Model / Reference
- 51-5007 FDA UDI
- Description
- H/S Catheters are latex free medical devices used to inject contrast media or saline into the uterus through the fluid lumen of the tube. This devices consist of a flexible (size 7FR) tube with a balloon at the distal end. Intended to be used during sonohysterography and Hysterosalpingography procedures. FDA UDI
Identifiers
- Catalog Number
- 51-5007 FDA UDI
- Primary DI / UDI-DI
- 00690521013742 FDA UDI
- 510(k) Number
- K032835 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Intrauterine imaging medium 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
Dimensions & Sizes
- Size
- Length — 28 Centimeter FDA UDICatheter Gauge — 7 French FDA UDI
Category: Intrauterine imaging medium catheter
Batrik H/S Catheter TM 7F by Batrik Medical Manufacturing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K032835 also covers:
- Batrik H/S Catheter TM 5F — Batrik Medical Manufacturing Inc
- HS Catheters — MEDGYN PRODUCTS, INC.
- HS Catheters — MEDGYN PRODUCTS, INC.
- HS Catheters — MEDGYN PRODUCTS, INC.
- HS Catheters — MEDGYN PRODUCTS, INC.
- HS Catheters — MEDGYN PRODUCTS, INC.
- HS catheters — MEDGYN PRODUCTS, INC.
- HSG Kits — MEDGYN PRODUCTS, INC.
- HSG Kits — MEDGYN PRODUCTS, INC.
- HSG Kits — MEDGYN PRODUCTS, INC.
- HSG Kits — MEDGYN PRODUCTS, INC.
- HSG Kits — MEDGYN PRODUCTS, INC.
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
- Batrik Medical Manufacturing Inc
Sources (1)
- FDA UDI 57afd777-1e2a-4ba6-9abc-b59a2178f622 38 fields · synced Jun 1, 2026