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Pro-Mag™ "Short Throw" Biopsy Needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 765116080
Identity
- Trade Name
- ProMag Needles EUDAMEDPro-Mag™ "Short Throw" Biopsy Needle FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- ProMag Needles EUDAMEDPro-Mag™ "Short Throw" Biopsy Needle 16ga x 8cm FDA UDI
- Model / Reference
- 765116080 EUDAMEDFDA UDI
- Description
- Pro-Mag™ "Short Throw" Biopsy Needle 16ga x 8cm FDA UDI
Identifiers
- Catalog Number
- 765116080 FDA UDI
- Primary DI / UDI-DI
- 20886333007107 EUDAMED00886333007103 FDA UDI
- Basic UDI-DI
- B-20886333007107 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Soft-tissue biopsy needle, single-use
Pro-Mag™ "Short Throw" Biopsy Needle by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy needle, single-use.
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
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- Inrad — Inrad · Class II
- CUSTOMED — Customed, Inc. · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Manual TruCut Biopsy Cannula — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI 8ede63b0-5862-4d36-abcc-ea5c998756f8 36 fields · synced Jul 8, 2026
- EUDAMED 98d8e35e-4cfb-475a-a585-ac650cce0138 61 fields · synced Jul 8, 2026