FDA.reportPublic FDA data

SPECULUX

Primary DI
25060489400059
Brand
SPECULUX
Company
EVEXAR MEDICAL LIMITED
Model
31063
Catalog number
00306
Device description
Self Illuminated Vaginal Speculum (Large, Screw Closure, with Smoke Tube)
Published
2016-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
15060489400052PackageGS125In Commercial Distribution
25060489400059PackageGS14In Commercial Distribution
05060489400055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506048940005215060489400052
2506048940005925060489400059
05060489400055050604894000555060489400055

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
739654197
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
05060489400116SPECULUX31071003222016-07-11
05060489400123SPECULUX31073003242016-07-11
05060489400130SPECULUX31074003252016-07-11
05060489400147SPECULUX31075003262016-07-11
15060489400038SPECULUX31061003042016-07-05
25060489400042SPECULUX31062003042016-07-05
25060489400066SPECULUX31065003082016-07-11
25060489400073SPECULUX31066003092016-07-11
25060489400080SPECULUX31067003102016-07-11
25060489400097SPECULUX31069003202016-07-11
25060489400103SPECULUX31070003212016-07-11
25060489400110SPECULUX31071003222016-07-11

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