AccessGUDID - DEVICE: Epsilon USA (G346ET01900)

GUDID

Device Identifier (DI) Information

Brand Name: Epsilon USA
Version or Model: ET-01-90
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EPSILON EYE CARE PRIVATE LIMITED

Primary DI Number: G346ET01900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 917922762 *Terms of Use

Device Description: Reiser Mendez Degree Gauge (90 Degrees at handle) Titanium

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?
37896	Corneal marker, reusable	A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMR	Marker, Ocular

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: Yes

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
Ethylene Oxide

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: 1b5b01f7-8058-40c6-85f8-a25ba2ffe027
Public Version Date: May 19, 2025
Public Version Number: 1
DI Record Publish Date: May 09, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (909) 984-4614
Email: epsilonusa1@gmail.com

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