Sil.Flex TC Pad 5 mm

GUDID 64710810117598

GALEMED CORPORATION

Laryngectomy tube, sterile
Primary Device ID64710810117598
NIH Device Record Key1569064d-780c-4b09-925e-587d5ecd5e9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSil.Flex
Version Model NumberDP00
Catalog NumberTC Pad 5 mm
Company DUNS656854379
Company NameGALEMED CORPORATION
Device Count10
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
GS124710810117590 [Primary]
GS164710810117598 [Package]
Contains: 24710810117590
Package: Carton [16 Units]
In Commercial Distribution
GS194710810117599 [Unit of Use]

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

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