Identity
- Trade Name
- ETHICON EUDAMEDCircular Sizer FDA UDI
- Generic Name
- Colorectal sizer FDA UDI
- Device Name
- Circular Sizer EUDAMEDThe Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with the head sizes of ETHICON Circular Staplers (Intraluminal Staplers). FDA UDI
- Model / Reference
- CS31 EUDAMEDFDA UDI
- Description
- The Circular Sizer is a non-sterile, stainless steel device sized 31 mm to correspond with the head sizes of ETHICON Circular Staplers (Intraluminal Staplers). FDA UDI
Identifiers
- Catalog Number
- CS31 FDA UDI
- Primary DI / UDI-DI
- 20705036015434 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000086N EUDAMED
- Direct Marketing DI
- 10705036015437 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- H020280 STAPLERS FOR OPEN SURGERY - ACCESSORIES EUDAMED
- GMDN Term
- Colorectal sizer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ethicon by Ethicon Endo-Surgery, LLC — Class I — 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 | 0705036a000086N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9d13830b-d5fb-492d-83b1-2c3a18eb1d45 61 fields · synced Jun 9, 2026
- FDA UDI 0fda8f51-cf0e-4a24-be45-9cc2a510b1b6 35 fields · synced May 30, 2026