Gore TIPS Set TSET1016

GUDID 25391526210028

Gore TIPS Set

CREGANNA UNLIMITED COMPANY

Portosystemic needle set
Primary Device ID25391526210028
NIH Device Record Keye313ce29-6d7e-450d-8017-1b383bcf6a94
Commercial Distribution StatusIn Commercial Distribution
Brand NameGore TIPS Set
Version Model NumberTSET1016
Catalog NumberTSET1016
Company DUNS985218606
Company NameCREGANNA UNLIMITED COMPANY
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

Device Dimensions

Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French
Needle Gauge16 Gauge
Catheter Gauge10 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool place

Device Identifiers

Device Issuing AgencyDevice ID
GS125391526210028 [Primary]

FDA Product Code

DYBIntroducer, Catheter

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 Date2016-09-23

Devices Manufactured by CREGANNA UNLIMITED COMPANY

05391526210154 - Trapper™ Exchange Device2019-10-07 Trapper™ Exchange Device
05391526210017 - Gore TIPS® Sheath2019-06-07 Gore TIPS® Sheath
05391526210109 - Lotus™ Introducer Set2019-06-07 Lotus™ Introducer Set, Small
05391526210116 - Lotus™ Introducer Set2019-06-07 Lotus™ Introducer Set, Large
05391526210253 - Attain Assist™ CS Access Catheter 2019-02-14 Attain Assist™ CS Access Catheter
05391526210031 - Zurpaz™ Steerable Sheath Set2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
05391526210048 - Zurpaz™ Steerable Sheath Set2019-01-23 Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
05391526210055 - Zurpaz™ Steerable Sheath Set2019-01-23 Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath

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