Identity
- Trade Name
- CUSTOMED FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 250MM, PINK FDA UDI
- Model / Reference
- 712057839825 FDA UDI
- Description
- CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 250MM, PINK FDA UDI
Identifiers
- Catalog Number
- 9001091825 FDA UDI
- Primary DI / UDI-DI
- M20890010918250 FDA UDI
- 510(k) Number
- K092338 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
Dimensions & Sizes
- Size
- Length — 250 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Category: Soft-tissue biopsy needle, single-use
Customed by Customed, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
- Chiba needle — Möller Medical GmbH · Class II
- Inrad — Inrad · 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
- Manual TruCut Biopsy Cannula — Möller Medical GmbH · Class II
Cleared under the same submission
K092338 also covers:
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- Caesar C — Medax Unipersonale Srl
- Caesar C — Medax Unipersonale Srl
- Caesar C — Medax Unipersonale Srl
- Caesar C — Medax Unipersonale Srl
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA UDI b2347fda-8fd0-4997-b251-036a9c312661 38 fields · synced Jun 1, 2026