AccessGUDID - DEVICE: Sterile Shield (07350101640029)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Shield
Version or Model: LAF-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Toul Meditech AB

Primary DI Number: 07350101640029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 427895198 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62934	Surgical dressing/drape kit, single-use	A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORC	Air Filter Portable Apparatus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45bd38bd-8d5a-4f26-a66f-65717f3704e1
Public Version Date: June 22, 2021
Public Version Number: 3
DI Record Publish Date: February 13, 2019