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Shaft obturator
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref BSHO04175
by Joimax, Inc.
Identity
- Trade Name
- Shaft obturator for endoscope shaft EUDAMEDShaft obturator FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Shaft obturator for endoscope shaft EUDAMEDFDA UDI
- Model / Reference
- BSHO04175 EUDAMEDFDA UDI
- Description
- Shaft obturator for endoscope shaft FDA UDI
Identifiers
- Catalog Number
- BSHO04175 FDA UDI
- Primary DI / UDI-DI
- 04250337120346 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371ENSCOBTGK EUDAMED
- Direct Marketing DI
- 04250337120346 EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 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
Shaft obturator by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
- USA Elite — Gyrus Acmi, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class I
- 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI f2650c57-dea4-413e-a70c-19cf32910493 36 fields · synced Jul 24, 2026
- EUDAMED 0dbeeb30-9635-4fa3-8048-48fec269a545 61 fields · synced Jul 24, 2026