Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMEDMammotome revolve FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Probe Guide EUDAMEDFDA UDI
- Model / Reference
- MG08B EUDAMEDFDA UDI
- Description
- Probe Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841911100782 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02E000003322TA EUDAMED
- 510(k) Number
- K943863 FDA UDI
- FDA Product Code
- IYN FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 8 Gauge FDA UDI
Category: Needle guide, single-use
Mammotome revolve by Devicor Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 — 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
Sources (2)
- FDA UDI 927b4352-e3a9-444e-9113-b6da10455f82 36 fields · synced Jun 19, 2026
- EUDAMED c0af9fd4-6b27-415c-a15f-5a83b096324f 61 fields · synced Jun 19, 2026