CareSpec 7-56441

GUDID 20816908010706

Vaginal Speculum, Single-Use (Small, Screw Closure)

CYALUME TECHNOLOGIES, INC.

Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use
Primary Device ID20816908010706
NIH Device Record Key4e02be59-45fc-4b79-82b0-49690030c955
Commercial Distribution StatusIn Commercial Distribution
Brand NameCareSpec
Version Model Number7-56441
Catalog Number7-56441
Company DUNS154779748
Company NameCYALUME TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-733-4034
Emailinfo@cyalumemed.com
Phone1-888-733-4034
Emailinfo@cyalumemed.com
Phone1-888-733-4034
Emailinfo@cyalumemed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816908010702 [Primary]
GS110816908010709 [Package]
Contains: 00816908010702
Package: Inner Pack [25 Units]
In Commercial Distribution
GS120816908010706 [Package]
Contains: 10816908010709
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-02
Device Publish Date2018-03-01

On-Brand Devices [CareSpec]

20816908010720Vaginal Speculum, Single-Use (Large, Screw Closure)
20816908010713Vaginal Speculum, Single-Use (Medium, Screw Closure)
20816908010706Vaginal Speculum, Single-Use (Small, Screw Closure)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.