DEVICE: Eli Ezer (00851158007706)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Eli Ezer
ETN-1800
In Commercial Distribution

U.S. OPHTHALMIC, L.L.C.
00851158007706
GS1

1
166760392 *Terms of Use
Non-Contact Tonometer
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35399 Ophthalmic tonometer, line-powered
An ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HKX Tonometer, Ac-Powered
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K180820 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
1181c039-24ca-487e-ae31-8ae610b2668f
January 12, 2021
1
January 04, 2021
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE