Identity
- Trade Name
- Basic Accessory Kit FDA UDI
- Generic Name
- Flexible video bronchoscope, reusable FDA UDI
- Device Name
- Galaxy system basic accessory kit FDA UDI
- Model / Reference
- 10000111 FDA UDI
- Description
- Galaxy system basic accessory kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850048825062 FDA UDI
- 510(k) Number
- K223144 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Basic Accessory Kit by Noah Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Noah Medical Corp.
Sources (1)
- FDA UDI b7a6680c-b535-464e-900e-3abf268a5b86 35 fields · synced Jun 8, 2026