CooperSurgical, Inc.

GUDID 30888937003247

Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French

Coopersurgical, Inc.

Oesophageal balloon catheter
Primary Device ID30888937003247
NIH Device Record Key65075d98-7480-4c50-b467-3a09b152d119
Commercial Distribution StatusIn Commercial Distribution
Brand NameCooperSurgical, Inc.
Version Model Number47-9005
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS120888937003240 [Package]
Contains: 60888937003248
Package: [5 Units]
In Commercial Distribution
GS130888937003247 [Package]
Contains: 60888937003248
Package: [20 Units]
In Commercial Distribution
GS160888937003248 [Primary]

FDA Product Code

GBACatheter, Balloon Type

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

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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