Identity
- Trade Name
- Stradis Medical, LLC FDA UDI
- Generic Name
- Cricothyrotomy kit, single-use FDA UDI
- Device Name
- Rapid Airway Introducer FDA UDI
- Model / Reference
- 010563-SH FDA UDI
- Description
- Rapid Airway Introducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- M752010563SH0 FDA UDI
- GMDN Term
- Cricothyrotomy kit, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cricothyrotomy kit, single-use
Stradis Medical, LLC by Stradis Medical, Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cricothyrotomy kit, single-use.
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- Pertrach — Engineered Medical Systems, LLC · Class II
- TACTICAL CricKIT — NORTH AMERICAN RESCUE, LLC. · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Stradis Medical, Llc
Sources (1)
- FDA UDI 77eff5b6-3219-49f2-a32a-da30e3e6a152 34 fields · synced Jun 1, 2026