DEVICE: DMV Ultra (00080875985909)

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Device Record History
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Device Identifier (DI) Information
DMV Ultra
590
In Commercial Distribution
590
DMV CORPORATION
00080875985909
GS1

1
084436906 *Terms of Use
Contact lens remover/inserter for hard and gp contact lenses
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Device Characteristics
Labeling does not contain MRI Safety Information
Yes
No
No
No
Yes
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?
42810 Rigid contact lens inserter/remover
A device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KYE Inserter/Remover Contact Lens
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K830496 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
f013beff-84aa-4af3-96e4-3a9ddeaf3e14
May 12, 2020
2
April 06, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00080875985916 10 00080875985909 In Commercial Distribution
10080875985906 100 00080875985909 In Commercial Distribution Pallet (Bag 100pcs)
20080875985903 500 00080875985909 In Commercial Distribution Pallet (Bag 500pcs)
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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