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Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX FDA UDI
- Generic Name
- Cochlear electrode array introducer, reusable FDA UDI
- Device Name
- Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series FDA UDI
- Model / Reference
- PW C-G-D 90 FDA UDI
- Description
- Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701354402201 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Cochlear electrode array introducer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 34 Centimeter FDA UDIWidth — 23 Centimeter FDA UDIHeight — 3 Centimeter FDA UDI
Category: Cochlear electrode array introducer, reusable
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX by Plasmabiotics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cochlear electrode array introducer, reusable.
- Nucleus — Cochlear · Class III
- Surgical Claw angled — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- Müller introducer — Spiggle & Theis Medizintechnik GmbH · Class I
- Nucleus — Cochlear · Class III
- Surgical Claw straight — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
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
- Plasmabiotics
Sources (2)
- FDA UDI e2204b22-06ef-4b15-9a1e-79816357e158 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026