AccessGUDID - DEVICE: EZ-Roll Cart (10841736113445)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Roll Cart
Version or Model: 6-020-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736113445
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: EZ-Roll Cart (Requires Accessory Cart Kit)

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):	Yes
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?
65581	Instrument transport trolley rack	A structure typically consisting of a frame on wheels with shelves and handles intended to be used with trays (not included) for the protective transport and short-term storage of reusable clinical instruments (typically endoscopes or surgical instruments). It is not a complete instrument transport trolley system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	Surgical Table Cushion

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: 6ed92bdb-3b7f-4c82-a6c2-eee6c4f1ed9b
Public Version Date: October 03, 2023
Public Version Number: 2
DI Record Publish Date: December 01, 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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-759-8766
Email: info@skytron.us

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