DEVICE: E.DL SPXL LENS MARKETING SAMPLE (00841668111895)

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Device Record History
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Device Identifier (DI) Information
E.DL SPXL LENS MARKETING SAMPLE
196 743
In Commercial Distribution

KATENA PRODUCTS, INC.
00841668111895
GS1

1
085668598 *Terms of Use
E.DL SPXL LENS MARKETING SAMPLE Box 10 use 196 747
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
47946 Ophthalmic diagnostic condensing lens
An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
5927acdd-2646-4644-a145-13b137e3fb20
June 17, 2022
3
September 22, 2016
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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
10841668111892 10 00841668111895 In Commercial Distribution Box
20841668111899 10 10841668111892 In Commercial Distribution Carton
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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
Yes
No
No CLOSE

Customer Contact

[?]
(973) 989-1600
globe@katena.com
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