CooperSurgical, Inc.

GUDID 00888937010008

16 Gauge Tip, 1 1/2" Needle

Coopersurgical, Inc.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID00888937010008
NIH Device Record Keyfbd274e6-2778-4570-959f-a4d9e1661e5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCooperSurgical, Inc.
Version Model Number900105
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 Usefalse
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937010008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

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 Date2016-07-29

On-Brand Devices [CooperSurgical, Inc.]

30888937003247Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
00888937011135Cervical Sizer
0088893701001516 Gauge Tip, 1 1/2" Needle, Curved
0088893701000816 Gauge Tip, 1 1/2" Needle
0088893700999614 Gauge Tip, 3" Needle, Curved, Long
0088893700998914 Gauge Tip, 3" Needle
208889370036911X Macro Bipolar Insert (Long)
208889370036841X Macro Bipolar Insert

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