AccessGUDID - DEVICE: Schaerer Medical USA (00810101300394)

GUDID

Device Identifier (DI) Information

Brand Name: Schaerer Medical USA
Version or Model: 73033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73033
Company Name: Schaerer Medical Usa, Inc.

Primary DI Number: 00810101300394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092820703 *Terms of Use

Device Description: ORTHO EQUIPMENT CART

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?
34910	Orthopaedic operating table accessory trolley	A cart designed as a framework on wheels with baskets, shelves, hooks and organizers used to store all the traction related accessory devices (e.g., patient supports, perineal post, traction boots, traction tensioners) that are required to put a patient in traction (e.g., the stretching of a broken limb during orthopaedic surgery). This trolley (cart) is used in association with an orthopaedic operating table.	Obsolete	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
No Device Sizes

Device Record Status

Public Device Record Key: 6defd0ce-fbef-4858-8dee-aa3cd2e92b2e
Public Version Date: September 26, 2022
Public Version Number: 1
DI Record Publish Date: September 16, 2022