AccessGUDID - DEVICE: AMSCO (00724995161309)

GUDID

Device Identifier (DI) Information

Brand Name: AMSCO
Version or Model: LD202
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P141211166
Company Name: STERIS CORPORATION

Primary DI Number: 00724995161309
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Dual Wall Controller is used with the AMSCO LD202 Lighting System.

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):	No
Over the Counter (OTC):	Yes
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?
62745	Medical device light source controller	A mains electricity (AC-powered) device intended to step down the electrical power from the mains to supply power to and provide control of (e.g., on/off) a light source associated with another medical device (e.g. surgical power tool). This controller may be operated through hand and/or foot controls. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZF	Device, medical examination, ac powered

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: d5c25ddb-fea8-4fc7-a9b9-089ce1c9e442
Public Version Date: November 07, 2023
Public Version Number: 2
DI Record Publish Date: March 31, 2021