Identity
- Trade Name
- Shaft obturator for intENTS cervical EUDAMEDintENTS® FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Shaft obturator for endoscope shaft EUDAMEDShaft obturator for intENTS cervical FDA UDI
- Model / Reference
- PSO141023 EUDAMEDFDA UDI
- Description
- Shaft obturator for intENTS cervical FDA UDI
Identifiers
- Catalog Number
- PSO141023 FDA UDI
- Primary DI / UDI-DI
- 04250337114659 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371ENSCOBTGK EUDAMED
- Direct Marketing DI
- 04250337114659 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany 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
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
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
Category: Rigid endoscope obturator
intENTS® by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Rigid endoscope obturator.
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- SHARK — Richard Wolf GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 61be832b-4572-49af-b71d-f56b1b4ea0ea 36 fields · synced Jul 11, 2026
- EUDAMED 16f88194-790b-4e5e-9ca7-3c7f99fc7c9e 61 fields · synced Jul 11, 2026