CYALUME TECHNOLOGIES, INC.

CYALUME TECHNOLOGIES, INC.

Address:96 Windsor St,West Springfield,MA,01089,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Speculum, Vaginal, Nonmetal (HIB) (5) Speculum, Vaginal, Nonmetal, Fiberoptic (HIC) (3) Source, Chemiluminescent Light (MPU) (2)

Premarket Exempt

Yes

Clear

SpecuLume - 00816908010627 Catalog Number : 7-34222

Device Description : Self Illuminated Vaginal Speculum (Medium, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : Yes

Device Count : 1

SpecuLume - 00816908010634 Catalog Number : 7-34221

Device Description : Self Illuminated Vaginal Speculum (Small, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : Yes

Device Count : 1

SpecuLume - 00816908010641 Catalog Number : 7-34223

Device Description : Self Illuminated Vaginal Speculum (Large, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : Yes

Device Count : 1

ViaLume - 00816908010658 Catalog Number : 7-45331

Device Description : Self Illuminated Vaginal Speculum (Small, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ViaLume - 00816908010665 Catalog Number : 7-45332

Device Description : Self Illuminated Vaginal Speculum (Medium, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ViaLume - 00816908010672 Catalog Number : 7-45333

Device Description : Self Illuminated Vaginal Speculum (Large, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

OnLite - 00816908010689 Catalog Number : 7-1028W

Device Description : Vaginal Illuminator (White)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : MPU

Prescription Use : Yes

Device Count : 1

OnLite - 00816908010696 Catalog Number : 7-1028B

Device Description : Vaginal Illuminator (Blue)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : MPU

Prescription Use : Yes

Device Count : 1

CareSpec - 00816908010702 Catalog Number : 7-56441

Device Description : Vaginal Speculum, Single-Use (Small, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

CareSpec - 00816908010719 Catalog Number : 7-56442

Device Description : Vaginal Speculum, Single-Use (Medium, Screw Closure)

Device Class : 2

Duns Number: 154779748

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

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