Identity
- Trade Name
- Mammotome FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Probe Guide FDA UDI
- Model / Reference
- G08U FDA UDI
- Description
- Probe Guide FDA UDI
Identifiers
- Catalog Number
- G08U FDA UDI
- Primary DI / UDI-DI
- 00841911101192 FDA UDI
- 510(k) Number
- K943863 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 8 Gauge FDA UDI
Category: Needle guide, single-use
Mammotome by Devicor Medical Products, Inc. — Class II — 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
K943863 also covers:
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome — Devicor Medical Products, Inc.
- Mammotome MammoTest — Devicor Medical Products, Inc.
- Mammotome MammoTest — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
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
- Devicor Medical Products, Inc.
Sources (1)
- FDA UDI 830ed922-3d03-4f6e-b487-9508427d0ac2 37 fields · synced Jun 8, 2026