Identity
- Trade Name
- HSG Tray FDA UDI
- Generic Name
- Fallopian tube catheterization kit FDA UDI
- Device Name
- For hysterosalpingography procedures FDA UDI
- Model / Reference
- 6050T FDA UDI
- Description
- For hysterosalpingography procedures FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937003262 FDA UDI
- 510(k) Number
- K920803 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Fallopian tube catheterization kit 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
Yes
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: Fallopian tube catheterization kit
HSG Tray by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fallopian tube catheterization kit.
- Cook — COOK INCORPORATED · Class II
- Novy — COOK INCORPORATED · Class II
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- Novy — COOK INCORPORATED · Class II
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- Novy — COOK INCORPORATED · Class II
- H/S Procedure Tray • 5 French — CooperSurgical, Inc. · Class II
- H/S Elliptosphere™ Procedure Tray • 5 French — CooperSurgical, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 5d22f1a4-df04-4e74-9c7b-8e8df317e578 34 fields · synced Jun 9, 2026