AccessGUDID - DEVICE: NA (00724995179786)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Shoulder Chair
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BF594
Company Name: STERIS CORPORATION

Primary DI Number: 00724995179786
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Shoulder Chair is used for open or arthroscopic procedures, features a unique, multi axis head positioning capability, which allows for easy intubation and head posturing.

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?
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
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: 50c46246-3c3c-4bc7-974c-d8522535a27a
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: June 14, 2021