Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Tracheal surgery dilator, single-use FDA UDI
- Device Name
- Curaplex Trach Hook, Stainless Steel FDA UDI
- Model / Reference
- 36029 FDA UDI
- Description
- Curaplex Trach Hook, Stainless Steel FDA UDI
Identifiers
- Catalog Number
- 36029 FDA UDI
- Primary DI / UDI-DI
- 00812277037494 FDA UDI
- FDA Product Code
- KCH FDA UDI
- GMDN Term
- Tracheal surgery dilator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheal surgery dilator, 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 Tracheal surgery dilator, single-use.
- MedSource Tracheostomy Hook — MEDSOURCE INTERNATIONAL LLC · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · 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 22523a17-fdc3-4858-99b5-bfde8f00be5a 34 fields · synced May 30, 2026