Identity
- Trade Name
- Coaxial sleeve Ø 1,50 (17G) FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Coaxial sleeve Ø 1,50 (17G) for PrimoCut Ø 1,20 (18G)x 200,sterile FDA UDI
- Model / Reference
- 413S150162 FDA UDI
- Description
- Coaxial sleeve Ø 1,50 (17G) for PrimoCut Ø 1,20 (18G)x 200,sterile FDA UDI
Identifiers
- Catalog Number
- 413S150162 FDA UDI
- Primary DI / UDI-DI
- 04048223127056 FDA UDI
- 510(k) Number
- K080674 FDA UDI
- FDA Product Code
- MJG FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Category: Needle guide, single-use
Coaxial sleeve Ø 1, 50 (17G) by Pajunk GmbH Medizintechnologie — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI b9ba7bbd-6a41-4dd7-82f9-c7b291c0a75c 37 fields · synced May 31, 2026