Galenica

GUDID 40888937012437

Galenica 1 Large Vaginal Speculum

Coopersurgical, Inc.

Vaginal speculum, single-use
Primary Device ID40888937012437
NIH Device Record Keybc1c4487-0246-4ae4-93a2-3f36456c6a37
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalenica
Version Model Number8617
Company DUNS801895244
Company NameCoopersurgical, Inc.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937012439 [Primary]
GS120888937012433 [Package]
Contains: 00888937012439
Package: [50 Units]
In Commercial Distribution
GS140888937012437 [Package]
Contains: 20888937012433
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Galenica]

20888937010125Galenica 10 Vaginal Specula • Large
40888937010112Galenica 10 Vaginal Specula • Medium
50888937010102Galenica 10 VAGINAL SPECULA • SMALL
40888937012437Galenica 1 Large Vaginal Speculum
40888937012420Galenica 1 Medium Vaginal Speculum
40888937012413Galenica 1 Small Vaginal Speculum

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