Identity
- Trade Name
- Signia™ EUDAMEDSignia FDA UDI
- Generic Name
- Motorized cutting stapler handpiece FDA UDI
- Device Name
- Signia Stapler Handle EUDAMEDPower Handle FDA UDI
- Model / Reference
- SIGPHANDLE EUDAMEDFDA UDI
- Description
- Power Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521543782 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B000010873 EUDAMED
- Direct Marketing DI
- 10884521543782 EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020380 STAPLERS, VIDEOSURGERY - ACCESSORIES EUDAMED
- GMDN Term
- Motorized cutting stapler handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Motorized cutting stapler handpiece
Signia by Covidien LP — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Motorized cutting stapler handpiece.
- iDrive Ultra — Covidien LP · Class II
- Signia — Covidien LP · Class II
Cleared under the same submission
K160176 also covers:
K201672 also covers:
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
- Covidien LP
Sources (2)
- FDA UDI 28f099be-0aa2-40df-b7f9-96a7f03ff9b6 36 fields · synced Jul 12, 2026
- EUDAMED 2e5b63a7-1286-46ad-970f-93ec497ddb34 61 fields · synced Jul 12, 2026