AccessGUDID - DEVICE: Ritter (00841709111068)

GUDID

Device Identifier (DI) Information

Brand Name: Ritter
Version or Model: 9A632001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9A632001
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709111068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Ritter Assist Handles are designed to offer patients a stable platform for accessing the 204 manual examination table and a sense of security during ingress, egress and positioning while on the table.

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):	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?
42812	Chair/stool armrest	A device designed to be attached to a chair or a stool to provide the occupant with arm support for comfort while sitting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBB	CHAIR, SURGICAL, 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: 6ff84b78-70d6-40aa-bb5c-e6ac1dc511ee
Public Version Date: July 28, 2020
Public Version Number: 1
DI Record Publish Date: July 20, 2020