16G Wallace Single Lumen Oocyte Needle

GUDID 30888937021135

16G Wallace Single Lumen Oocyte Needle (Box of 10)

Coopersurgical, Inc.

IVF oocyte aspiration needle, single-use
Primary Device ID30888937021135
NIH Device Record Key223d4461-bb6e-4a45-b726-7fc7d0e0c457
Commercial Distribution StatusIn Commercial Distribution
Brand Name16G Wallace Single Lumen Oocyte Needle
Version Model NumberON1633
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 Dimensions

Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937021134 [Primary]
GS120888937021138 [Package]
Contains: 00888937021134
Package: Box [10 Units]
In Commercial Distribution
GS130888937021135 [Package]
Contains: 20888937021138
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQENeedle, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

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