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Proximate
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TCD75Ref TCT55Ref TLC75Ref TLC10Ref PXR35
Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- PROXIMATE Reloadable Linear Cutter with Safety Lock-out EUDAMEDProximate Reloadable Linear Cutter With Safety Lock-Out, 100mm FDA UDIProximate Reloadable Linear Cutter With Safety Lock-out. 55mm linear cutter. FDA UDIProximate Reloadable Linear Cutter With Safety Lock-Out, 75mm FDA UDIProximate Reloadable Linear Cutter With Safety Lock-Out-75mm FDA UDI
- Model / Reference
- TCD75 EUDAMEDFDA UDITLC10 EUDAMEDFDA UDITCT55 EUDAMEDFDA UDITLC75 EUDAMEDFDA UDIPXR35 EUDAMED
- Description
- Proximate Reloadable Linear Cutter With Safety Lock-Out, 100mm FDA UDIProximate Reloadable Linear Cutter With Safety Lock-out. 55mm linear cutter. FDA UDIProximate Reloadable Linear Cutter With Safety Lock-Out, 75mm FDA UDIProximate Reloadable Linear Cutter With Safety Lock-Out-75mm FDA UDI
Identifiers
- Catalog Number
- TLC10 FDA UDITCT55 FDA UDITLC75 FDA UDITCD75 FDA UDI
- Primary DI / UDI-DI
- 10705036013112 EUDAMEDFDA UDI10705036003120 EUDAMEDFDA UDI10705036013143 EUDAMEDFDA UDI10705036013211 EUDAMEDFDA UDID-USMF000013107000069MX EUDAMED
- Basic UDI-DI
- 0705036a000476Y EUDAMEDB-USMF000013107000069MX EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass 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
Yes
EUDAMEDEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
MR Conditional FDA UDI
Category: Open-surgery manual linear cutting stapler, single-use
Proximate by Ethicon Endo-Surgery, LLC — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
- GIA — Covidien LP · Class II
- ZHY series of disposable auto linear stapler and cartridge — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Circumcision Staplers — Sinolinks Medical Innovation, Inc. · Class IIa
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Cartridge for Disposable Linear Cutter — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Endoscopic Linear Cutter Staplers and Cartridges — ChangZhou 3R Medical Device Technology Co.,Ltd · Class IIb
- Disposable Foreskin Stapler — Jiangsu Celtics MediTech Co.,Ltd. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0705036a000476Y | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0705036a000476Y | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (9)
- EUDAMED b803e1af-0871-4155-a3a3-69ff2fb6f550 61 fields · synced Jul 28, 2026
- FDA UDI 83511ed3-6f91-4857-be48-44407fcde1df 35 fields · synced May 30, 2026
- FDA UDI 79064ad8-9852-41b4-92df-db0f657b5871 35 fields · synced May 30, 2026
- FDA UDI cd819f20-ffa9-43ee-809d-a2aa46f5ba44 35 fields · synced May 30, 2026
- FDA UDI c12c1a70-7897-4298-9867-11ea598e7029 35 fields · synced May 30, 2026
- EUDAMED b748b92b-9d92-4c2d-a294-91456b49de39 61 fields · synced Jun 20, 2026
- EUDAMED ed059b53-b12b-429e-be2d-273951268597 61 fields · synced Jun 20, 2026
- EUDAMED c8c5dfed-8c35-4092-892b-b5cc127da3e5 61 fields · synced Jul 10, 2026
- EUDAMED dfa40750-9129-4cce-8070-cab9099bd437 61 fields · synced Jul 17, 2026