Identity
- Trade Name
- SourceMark FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Model / Reference
- M0912 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813799000096 FDA UDI
- FDA Product Code
- BSR FDA UDI
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5790 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
No
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
Category: Artificial airway stylet, single-use
SourceMark by Sourcemark, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial airway stylet, single-use.
- Mallinckrodt — Covidien LP · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Shiley — Covidien LP · Class I
- SHERIDAN — TELEFLEX INCORPORATED · Class I
- Curaplex — BOUND TREE MEDICAL, 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sourcemark, Llc.
Sources (1)
- FDA UDI 578b672f-1231-4095-a99f-f0badba29eb6 32 fields · synced Jun 8, 2026