AccessGUDID - DEVICE: ME-CHECK 4 (08056389701405)

GUDID

Device Identifier (DI) Information

Brand Name: ME-CHECK 4
Version or Model: ME-CHECK 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ME-CHECK 4
Company Name: ESPANSIONE MARKETING SPA

Primary DI Number: 08056389701405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339474539 *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):	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?
58860	Multi-purpose digital medical camera lens, extraocular	A non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the surface of the eye and adjacent areas. It may use white and/or blue light for the capture of specialized images (e.g., dry eye). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

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: 3eb2270c-58f6-4351-82a8-46edd341d3ad
Public Version Date: April 13, 2023
Public Version Number: 1
DI Record Publish Date: April 05, 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

[?]

No Customer Contact currently defined

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