DEVICE: Clement Clarke Ophthalmic (05060179470375)

Device Identifier (DI) Information

Clement Clarke Ophthalmic
7006001
In Commercial Distribution
7006001
HAAG-STREIT UK LIMITED
05060179470375
GS1

1
504108242 *Terms of Use
RAF BINOCULAR GAUGE
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
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?
63587 Ophthalmic binocular gauge
A noninvasive, hand-held, manual device intended to be used during an eye examination to determine objective and subjective convergence points, examine accommodation, and determine the master eye. Often called a Royal Air Force (RAF) convergence rule or RAF binocular gauge, it consists of a rule (typically 50cm long and multi-sided for taking different measurements) with a sliding test panel (typically multi-sided to allow different tests); it may have a handle at one end and a Y-shaped face rest at the other. Testing includes measuring the near distance at which, e.g., double vision is observed. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HLE Ruler, Nearpoint (Punctometer)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

aa02e6ee-27f9-4c80-8ef9-bf0c288b00c6
November 09, 2023
4
August 05, 2016
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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4401279414969
twhay@ccholdingsltd.com
CLOSE