AccessGUDID - DEVICE: econo-liner (00850045406301)

GUDID

Device Identifier (DI) Information

Brand Name: econo-liner
Version or Model: EL1424
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EL1424
Company Name: General Hospital Supply Corp

Primary DI Number: 00850045406301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 055852834 *Terms of Use

Device Description: Tray Liner 14 x 24

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:	Yes
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?
61664	Instrument tray liner	A durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp clinical instruments (typically endoscopes or surgical instruments) and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRP	Tray, Surgical

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: 8205c302-a3e2-4805-bd34-702b49a615ea
Public Version Date: October 28, 2022
Public Version Number: 1
DI Record Publish Date: October 20, 2022

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: 10850045406308 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

[?]

No Customer Contact currently defined

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