Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®

GUDID 20888937012747

Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®

Coopersurgical, Inc.

Uterine manipulator, single-use
Primary Device ID20888937012747
NIH Device Record Keye970f913-56e6-48b0-bf1f-9a277f881e5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®
Version Model NumberAD750-KE30
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 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
GS100888937012743 [Primary]
GS120888937012747 [Package]
Contains: 00888937012743
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-09-23

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00888937028324 - UTM2026-02-12 UTM Transfer Medium
00888937028577 - Flushing Medium2026-02-12 Flushing Medium without Heparin. 125 ml

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