Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- LARYNGOSCOPE BLADE,FO,MAC SZ1,DISP FDA UDI
- Model / Reference
- B5010 FDA UDI
- Description
- LARYNGOSCOPE BLADE,FO,MAC SZ1,DISP FDA UDI
Identifiers
- Catalog Number
- 301-B5010 FDA UDI
- Primary DI / UDI-DI
- 00810071636998 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Laryngoscope blade, 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Laryngoscope blade, single-use
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laryngoscope blade, single-use.
- BriteBlade Pro Single-Use Fiber Optic Robertshaw 0 — FLEXICARE MEDICAL LIMITED · Class I
- NOVALITE — NOVAMED-USA · Class I
- Vital Signs™ — VYAIRE MEDICAL, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- IntuBrite Sterile — SALTER LABS · Class I
- SunMed — SunMed · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- Disposable Conventional Laryngoscope Blade — Maco International · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI a793f534-10ea-4be0-84b0-77557c1f9e5f 34 fields · synced Jun 6, 2026