Identity
- Trade Name
- Galactography Kit FDA UDI
- Generic Name
- Breast ductography cannula FDA UDI
- Device Name
- Galactography Kit 30ga with Straight Cannula FDA UDI
- Model / Reference
- DGK002SX FDA UDI
- Description
- Galactography Kit 30ga with Straight Cannula FDA UDI
Identifiers
- Catalog Number
- DGK002SX FDA UDI
- Primary DI / UDI-DI
- 00886333001576 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Breast ductography cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
Yes
FDA UDI
Category: Breast ductography cannula
Galactography Kit by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast ductography cannula.
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- Jabczenski — COOK INCORPORATED · Class I
- GALACTOGRAPHY INFUSION, 30 GA — RANFAC CORP. · Class I
- GALACTOGRAPHY INFUSION, 31 GA — RANFAC CORP. · Class I
- Galactography Kit — Argon Medical Devices, 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 |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 3c07e5e8-09c5-43c3-89cb-792699381e78 36 fields · synced Jun 9, 2026