DEVICE: SPECULUX (05060489400031)

Device Identifier (DI) Information

SPECULUX
31061
In Commercial Distribution
00304
EVEXAR MEDICAL LIMITED
05060489400031
GS1

1
739654197 *Terms of Use
Self Illuminated Vaginal Speculum (Small, Screw Closure, with Smoke Tube)
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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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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
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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 Record Status

2e2af0fa-e093-47b9-9508-5d20f66e40b8
March 29, 2018
2
July 05, 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
15060489400038 25 05060489400031 In Commercial Distribution Carton
25060489400035 4 15060489400038 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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