AccessGUDID - DEVICE: Epsilon USA (G346EB21I0)

GUDID

Device Identifier (DI) Information

Brand Name: Epsilon USA
Version or Model: EB-21I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EPSILON EYE CARE PRIVATE LIMITED

Primary DI Number: G346EB21I0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 917922762 *Terms of Use

Device Description: Bi-Manual Irrigator Dual Port 22G

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?
35787	Ophthalmic calliper	A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOE	Caliper, 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: 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: 13f55f7c-f30d-4dce-8951-e246afe7dffe
Public Version Date: November 07, 2023
Public Version Number: 1
DI Record Publish Date: October 30, 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: 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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