AccessGUDID - DEVICE: SchureMed (00810014600420)

GUDID

Device Identifier (DI) Information

Brand Name: SchureMed
Version or Model: 800-0074-B-INT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-0074-B-INT
Company Name: SCHUERCH CORPORATION

Primary DI Number: 00810014600420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964322929 *Terms of Use

Device Description: Berchtold Shoulder Chair Dolly (INT)

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?
38664	Operating table accessory trolley	A cart typically designed as a framework on wheels with baskets, shelves, hooks and organizers that is used to store the operating table accessories in an orderly and hygienic manner. This trolley (cart) may be brought into the operation room (OR) so that a choice of operating table accessories, or accessories for a specific surgical procedure is made readily available.	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: 3ab05744-1f56-496e-b43a-4c4992b714ab
Public Version Date: June 07, 2021
Public Version Number: 2
DI Record Publish Date: June 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 781-982-7000
Email: lisa@schuremed.com

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