AccessGUDID - DEVICE: Ellex (09342395000557)

GUDID

Device Identifier (DI) Information

Brand Name: Ellex
Version or Model: COLUMN_LV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELLEX MEDICAL PTY LTD

Primary DI Number: 09342395000557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 756138509 *Terms of Use

Device Description: No description.

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?
65697	Transportable medical equipment stand, electrically-powered	An electrically-powered transportable device [e.g., on wheels or easily movable] designed to support medical equipment (e.g., monitors, pumps, consoles) used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It includes an electronic feature (electrical-articulation and/or an integrated battery to provide power for equipment). The equipment to be supported is not included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRJ	Table, Instrument, Powered, Ophthalmic

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: 26b58b0b-ab17-4509-b6fe-3ccb04ec965c
Public Version Date: December 11, 2024
Public Version Number: 3
DI Record Publish Date: June 09, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 999-999-9999
Email: xxx@xx.xx

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