AccessGUDID - DEVICE: "L" type anesthesia screen (10841736113421)

GUDID

Device Identifier (DI) Information

Brand Name: "L" type anesthesia screen
Version or Model: 6-020-04-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736113421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: "L" type anesthesia screen with two adjustable wings, without clamp [(Sure Clamp XL 6-040-11 recommended ) (1 ea.)]

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:	No
Prescription Use (Rx):	Yes
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?
35501	Anaesthesia screen	A frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	Surgical Table Cushion

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: No
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: 84fc6834-2775-4790-a5f2-1b214d0f2bad
Public Version Date: October 23, 2019
Public Version Number: 1
DI Record Publish Date: October 15, 2019