Identity
- Trade Name
- Insighter FDA UDI
- Generic Name
- Video intubation laryngoscope blade FDA UDI
- Model / Reference
- SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970831723277 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Video intubation laryngoscope blade 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
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
Category: Video intubation laryngoscope blade
Insighter by Shenzhen Insighters Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Video intubation laryngoscope blade.
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- Sensorendo — Sensorendo Medical Technology (Zhuhai) Co., Ltd. · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- OneScope Pro — One-AI Healthcare, Inc · 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
- Shenzhen Insighters Medical Technology Co., Ltd.
Sources (1)
- FDA UDI b0e9c49e-318e-4c79-b082-7e59c45d2640 32 fields · synced May 30, 2026