TC Pad 10 mm Sil.Flex

GUDID 64710810117604

GALEMED CORPORATION

Laryngectomy tube, sterile
Primary Device ID64710810117604
NIH Device Record Key8603eae3-ec2c-4ef7-abf5-d736b89ccef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTC Pad 10 mm
Version Model NumberDP01
Catalog NumberSil.Flex
Company DUNS656854379
Company NameGALEMED CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS124710810117606 [Primary]
GS164710810117604 [Package]
Contains: 24710810117606
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

CBHDevice, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-15

Devices Manufactured by GALEMED CORPORATION

04710810105265 - Babi.Plus2020-05-04
04710810093579 - Babi.Plus2020-05-04
04710810105258 - JITTO2020-04-21
04710810119897 - JITTO2020-04-21
44710810119895 - JITTO2019-03-26
44710810084476 - N/A2018-08-23
44710810085336 - N/A2018-08-23
44710810080386 - N/A2018-07-06

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