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Senhance
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref X0007018Model Senhance Surgical Instruments
Identity
- Trade Name
- Babcock Forceps, Long Ø 5 mm x 410 mm EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical forceps, reusable FDA UDI
- Device Name
- Babcock Forceps, Long FDA UDI
- Model / Reference
- X0007018 EUDAMEDFDA UDISenhance Surgical Instruments EUDAMED
- Description
- Babcock Forceps, Long FDA UDI
Identifiers
- Catalog Number
- 200-11022 FDA UDI
- Primary DI / UDI-DI
- 00815440020118 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD005UM EUDAMED
- Direct Marketing DI
- 00815440020118 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE EUDAMED
- GMDN Term
- Robotic surgical forceps, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 410 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Robotic surgical forceps, reusable
Senhance by Asensus Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical forceps, reusable.
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Kocher Grasper Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class IIa
- Fundus Grasper Ø 5 mm x 240 mm — Asensus Surgical Italia S.r.l. · Class IIa
- Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class I
- Right Angle Dissector, Long Ø 10 mm x length 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Monopolar L-Hook Electrode Ø 5 mm x 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
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
- Asensus Surgical, Inc.
Sources (2)
- FDA UDI e071a916-5a35-4a44-bd25-5744367be4bc 35 fields · synced Sep 18, 2026
- EUDAMED d123dd08-7b13-4377-b9cb-0fbab4ad35c7 61 fields · synced Sep 18, 2026