Identity
- Trade Name
- CONMED FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- Detachable Endo Pocket EUDAMEDEndo Pouch FDA UDI
- Model / Reference
- SB936 EUDAMEDFDA UDI
- Description
- Endo Pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04714127860763 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04714127860763 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020107 MINIMALLY INVASIVE SURGERY RECOVERY BAGS EUDAMED
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Detachable Endo Pocket by Unimax Medical Systems Inc. — Class IIa — 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-04714127860763 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 39c4b90a-88e1-4f35-8024-c4cda5f2f80a 61 fields · synced Oct 7, 2026
- FDA UDI 0622a69a-4abf-4499-860a-6761e3ae5743 33 fields · synced May 30, 2026