DEVICE: Medetz Surgical Instruments (G2231113910)

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Device Record History
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Device Identifier (DI) Information
Medetz Surgical Instruments
11-1391
In Commercial Distribution

Medetz Surgical Instruments LLC
G2231113910
HIBCC

1
876570990 *Terms of Use
Braunstein Fixed Caliper 3.5mm & 4.0mm DBL-Ended "U" shaped tips, Flat Stock, 70mm Overall Length, 17-4 Stainless Steel
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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?
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
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FDA Product Code

[?]
Product Code Product Code Name
HOE Caliper, Ophthalmic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
342076a9-9549-449b-bea4-07946a38b2df
June 12, 2025
1
June 04, 2025
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
8004205135
emichaels@medetzsurgical.com
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