Identity
- Trade Name
- MANOMETER FDA UDI
- Generic Name
- Cerebrospinal fluid manometer, mechanical FDA UDI
- Device Name
- 001163-38F FDA UDI
- Model / Reference
- 001163-38F FDA UDI
- Description
- 001163-38F FDA UDI
Identifiers
- Catalog Number
- 001163-38F FDA UDI
- Primary DI / UDI-DI
- 04048223049860 FDA UDI
- 510(k) Number
- K170305 FDA UDI
- FDA Product Code
- FMJ FDA UDI
- GMDN Term
- Cerebrospinal fluid manometer, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2500 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
No
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: Cerebrospinal fluid manometer, mechanical
Manometer by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid manometer, mechanical.
Cleared under the same submission
K170305 also covers:
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
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 954fa6d5-51d9-4e27-b199-b63571557345 37 fields · synced Jun 8, 2026