Identity
- Trade Name
- Stylus FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- GUARDED SLIT KNIFE FULL HDL-3.2MM ANG FDA UDI
- Model / Reference
- 52-3261G FDA UDI
- Description
- GUARDED SLIT KNIFE FULL HDL-3.2MM ANG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848782026401 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Category: Scalpel, single-use
Stylus by Surgical Specialties México, S. de R.L. de C.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Scalpel, single-use.
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- Unique Edge — Unique Technologies, Inc. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Surgical Specialties México, S. de R.L. de C.V.
Sources (1)
- FDA UDI da936611-c6fa-4c86-a29a-6cf1fd57cc8d 35 fields · synced Jun 8, 2026