FDA.reportPublic FDA data

SPECULUX

Primary DI
05060489400116
Brand
SPECULUX
Company
EVEXAR MEDICAL LIMITED
Model
31071
Catalog number
00322
Device description
Self Illuminated Vaginal Speculum (Large, Screw Closure)
Published
2016-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060489400113PackageGS125In Commercial Distribution
25060489400110PackageGS14In Commercial Distribution
05060489400116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506048940011315060489400113
2506048940011025060489400110
05060489400116050604894001165060489400116

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
999-999-9999info@evexar.com

Regulatory Flags#

DUNS number
739654197
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060489400031SPECULUX31061003042016-07-05
05060489400048SPECULUX31062003042016-07-05
05060489400055SPECULUX31063003062016-07-11
05060489400062SPECULUX31065003082016-07-11
05060489400079SPECULUX31066003092016-07-11
05060489400086SPECULUX31067003102016-07-11
05060489400093SPECULUX31069003202016-07-11
05060489400109SPECULUX31070003212016-07-11
05060489400123SPECULUX31073003242016-07-11
05060489400130SPECULUX31074003252016-07-11
05060489400147SPECULUX31075003262016-07-11
15060489400038SPECULUX31061003042016-07-05
25060489400042SPECULUX31062003042016-07-05
25060489400059SPECULUX31063003062016-07-11
25060489400066SPECULUX31065003082016-07-11
25060489400073SPECULUX31066003092016-07-11
25060489400080SPECULUX31067003102016-07-11
25060489400097SPECULUX31069003202016-07-11
25060489400103SPECULUX31070003212016-07-11
25060489400110SPECULUX31071003222016-07-11

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