DEVICE: SPECULUX (05060489400093)

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Device Identifier (DI) Information

SPECULUX
31069
00320
EVEXAR MEDICAL LIMITED
05060489400093
GS1
1
Self Illuminated Vaginal Speculum (Small, Screw Closure)
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vaginal speculum, single-use A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HIB Speculum, Vaginal, Nonmetal
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Small
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Device Status

In Commercial Distribution
July 11, 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
25060489400097 4 15060489400090 In Commercial Distribution Carton
15060489400090 25 05060489400093 In Commercial Distribution Carton
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
999-999-9999
info@evexar.com
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