AccessGUDID - DEVICE: Schaerer Medical USA (00810101300660)

GUDID

Device Identifier (DI) Information

Brand Name: Schaerer Medical USA
Version or Model: 528-0146-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 528-0146-00
Company Name: Schaerer Medical Usa, Inc.

Primary DI Number: 00810101300660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092820703 *Terms of Use

Device Description: X-RAY ARM BOARD PAD

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?
37047	Arm procedure positioner, reusable	A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

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
Height: 2 Inch

Device Record Status

Public Device Record Key: ff6608f0-f204-4bcb-8533-e7f8cd4ff637
Public Version Date: September 26, 2022
Public Version Number: 1
DI Record Publish Date: September 16, 2022