Identity
- Trade Name
- Sterile Shield FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02 has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02 is attached on the Operio device on the outlet of the HEPA filtered ultra clean air. Instructions on how to use and mount the sterile shield LAF 02 is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction. FDA UDI
- Model / Reference
- LAF-02 FDA UDI
- Description
- The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02 has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02 is attached on the Operio device on the outlet of the HEPA filtered ultra clean air. Instructions on how to use and mount the sterile shield LAF 02 is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350101640029 FDA UDI
- FDA Product Code
- ORC FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 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
No
FDA UDI
Category: Surgical dressing/drape kit, single-use
Sterile Shield by Toul Meditech AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Toul Meditech AB
Sources (1)
- FDA UDI 45bd38bd-8d5a-4f26-a66f-65717f3704e1 33 fields · synced May 30, 2026