Single Use Silc Cup with tubing (Obstetrics)

GUDID 07612367009355

Single Use Silc Cup with tubing (Obstetrics) The Single Use Silc Cup is intended to assist a clinician in the vacuum delivery of an infant during childbirth. The device is single use.

Medela AG

Foetal vacuum extraction system cup, single-use
Primary Device ID07612367009355
NIH Device Record Keye3df1593-519d-4edf-b252-33683949b12d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Silc Cup with tubing (Obstetrics)
Version Model Number077.0791
Company DUNS488293218
Company NameMedela AG
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com
Phone+1-877-735-1626
EmailInfo-healthcare@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367009355 [Primary]
GS107612367037815 [Package]
Package: [25 Units]
Discontinued: 2022-05-31
In Commercial Distribution
GS107612367077088 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-25
Device Publish Date2019-05-13

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