AccessGUDID - DEVICE: Midmark (00841709113253)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: 9A627001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9A627001
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709113253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Adjustable Arm System (arms only) is designed to offer patients a stable platform in accessing the table and a sense of security during positioning. Arms rotate and lock into one of three positions and are easily removable.

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
FRK	CHAIR, EXAMINATION AND TREATMENT

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: 0184c2ac-4fb2-4b52-a9e3-a8a96ffe9cdf
Public Version Date: March 02, 2020
Public Version Number: 1
DI Record Publish Date: February 21, 2020