Identity
- Trade Name
- ETHICON EUDAMEDN/A FDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- ETHICON Linear Cutter EUDAMED75mm Linear Cutter for use with Selectable Reload, No cartridge Included FDA UDI
- Model / Reference
- NTLC75 EUDAMEDFDA UDI
- Description
- 75mm Linear Cutter for use with Selectable Reload, No cartridge Included FDA UDI
Identifiers
- Catalog Number
- NTLC75 FDA UDI
- Primary DI / UDI-DI
- 10705036002628 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000396Z EUDAMED
- 510(k) Number
- K092577 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
Ethicon by Ethicon Endo-Surgery, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000396Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED e15f0810-c585-4cb1-a9ae-39c418bac85c 61 fields · synced Jun 9, 2026
- FDA UDI 543fe271-d34e-44eb-8faa-a4c4fbf73120 36 fields · synced May 30, 2026