Identity
- Trade Name
- EndoWrist Stapler Release Kit, English EUDAMEDEndoWrist FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Stapler Release Kit EUDAMEDSTAPLER RELEASE KIT,ENGLISH,IS4000 FDA UDI
- Model / Reference
- 381215 EUDAMEDFDA UDI
- Description
- STAPLER RELEASE KIT,ENGLISH,IS4000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874113912 EUDAMEDFDA UDI
- Basic UDI-DI
- 08868741201637K EUDAMED
- Direct Marketing DI
- 00886874113912 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical torque wrench, reusable
EndoWrist by Intuitive Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical torque wrench, reusable.
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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
- Intuitive Surgical, Inc.
Sources (2)
- FDA UDI 997a057c-0a20-4ffc-bde6-9f7b4a5102a1 33 fields · synced Jun 19, 2026
- EUDAMED 07efa17e-3e3f-4eca-992b-d75c9d542139 61 fields · synced Jun 19, 2026