Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Haemorrhoidal surgical stapler, single-use FDA UDI
- Device Name
- 33mm PROXIMATE HCS, Procedure for Prolapse and Hemorrhoids (PPH) Set FDA UDI
- Model / Reference
- PPH01 EUDAMEDFDA UDI
- Description
- 33mm PROXIMATE HCS, Procedure for Prolapse and Hemorrhoids (PPH) Set FDA UDI
Identifiers
- Catalog Number
- PPH01 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000028MH EUDAMED10705036012993 FDA UDI
- Basic UDI-DI
- B-USMF000013107000028MH EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H0203020101 SINGLE-USE CURVED CIRCULAR STAPLERS FOR VIDEOSURGERY EUDAMED
- GMDN Term
- Haemorrhoidal surgical stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Proximate by Ethicon Endo-Surgery, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000028MH | 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 (2)
- EUDAMED 809abc95-7803-4288-842a-0b6b7ead131c 61 fields · synced Jul 18, 2026
- FDA UDI 40297dd7-bee5-43a1-b819-f18cf8bcf4cc 35 fields · synced May 30, 2026