Sitz Bath

GUDID 00616784422824

Sitz Bath with Attachment and instructions 2.1qt. mauve

DYNAREX CORPORATION

Sitz bath kit, single-use
Primary Device ID00616784422824
NIH Device Record Keya532e725-5ceb-4ab8-b7ec-51dac9bea6ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSitz Bath
Version Model Number4228
Company DUNS008124539
Company NameDYNAREX 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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784422824 [Unit of Use]
GS100616784422831 [Primary]

FDA Product Code

KTCBath, Sitz, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-09
Device Publish Date2021-09-01

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