AccessGUDID - DEVICE: INAMI (04547451026280)

GUDID

Device Identifier (DI) Information

Brand Name: INAMI
Version or Model: L-2510HB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INAMI & CO., LTD.

Primary DI Number: 04547451026280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690688742 *Terms of Use

Device Description: L-2510 INAMI Synoptiscope with standard slides, Haidinger Brush device

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?
36058	Synoptophore	An electrically-powered ophthalmic device intended to for the evaluation and training of a patient's binocular function, i.e., the ability of the two eyes to focus on a single object. It is used for diagnosing strabismus (squint), a deviation of the eye which the patient cannot overcome and present in variants such as stereoscopy (vision in depth), amblyopia otherwise known as lazy eye (dimness of vision without apparent disease of the eye), and diplopia [exotropia (outward eye deviation) or esotropia (one or both eyes turn inward)]. It typically consists of a base with twin vision tubes (adjustable in many axes) providing images and illumination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJQ	Stereoscope, Ac-Powered

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: d0373c27-3010-47b6-af0e-0e5be3704818
Public Version Date: March 14, 2025
Public Version Number: 1
DI Record Publish Date: March 06, 2025

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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