Identity
- Trade Name
- MITEK FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Button top obturator for 5.9 mm sheath compatible with Mitek Lock 270 mm length FDA UDI
- Model / Reference
- 242254 FDA UDI
- Description
- Button top obturator for 5.9 mm sheath compatible with Mitek Lock 270 mm length FDA UDI
Identifiers
- Catalog Number
- 242254 FDA UDI
- Primary DI / UDI-DI
- 10886705029129 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscope obturator
Mitek by Medos International Sàrl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
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- USA Elite — Gyrus Acmi, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class I
- SHARK — Richard Wolf GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI ce8e7b10-6510-4fd3-8fdf-8b0bb6226b67 35 fields · synced Jun 1, 2026