Bioteque Taiwan Ltd.

GUDID 04719894432243

Bioteque Taiwan Ltd.

Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator
Primary Device ID04719894432243
NIH Device Record Key6e768228-ecdc-40dd-a556-2b2854aff420
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioteque Taiwan Ltd.
Version Model NumberDT-A
Company DUNS657769858
Company NameBioteque Taiwan Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719894432243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDXDilator, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-16
Device Publish Date2024-04-08

On-Brand Devices [Bioteque Taiwan Ltd.]

04719894432229DT-A/L
04719894432212DT-A/M
04719894432205DT-A/S
04719894433370RD003-P
04719894433011UI 4.0
04719894432885UMI4.5K
04719894432953UMI4.5
04719894432854BA100
04719894432809UIC5FAX
04719894432793UIC5FA
04719894432786UIC5F
04719894432687BA001
04719894432670BA05F-ST
04719894432663BA071F
04719894432656BA051F
04719894432649BA07F
04719894432632BA05F
04719894432557WC-400MM
04719894432496OS265BA-3
04719894432489OS265BA-2
04719894432472OS265BA-1
04719894432403RD003
04719894432328M0015
04719894432311M0014
04719894432304DT-C
04719894432298DT-B
04719894432281DT-B/XL
04719894432274DT-B/L
04719894432267DT-B/M
04719894432250DT-B/S
04719894432243DT-A
04719894432236DT-A/XL

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