Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Rigid intubation laryngoscope, single-use FDA UDI
- Device Name
- MAC 3.5,STANDARD,DISP.,CURAVIEW FO,GREEN SYSTEM,COMBO FDA UDI
- Model / Reference
- 301-FO-MAC-35-S FDA UDI
- Description
- MAC 3.5,STANDARD,DISP.,CURAVIEW FO,GREEN SYSTEM,COMBO FDA UDI
Identifiers
- Catalog Number
- 301-FO-MAC-35-S FDA UDI
- Primary DI / UDI-DI
- 00812277038002 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Rigid intubation laryngoscope, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Rigid intubation laryngoscope, single-use
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI e1c9116e-6a8a-40ce-8ed5-34133c3713c7 34 fields · synced Jun 6, 2026