PTFE Peelable Introducer Kit 7090

GUDID 10821329000529

Greatbatch Ltd

Vascular catheter introduction set, nonimplantable
Primary Device ID10821329000529
NIH Device Record Keyad74cd97-37b3-42a4-95f4-f3c1afa13299
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTFE Peelable Introducer Kit
Version Model Number667090-351
Catalog Number7090
Company DUNS968623467
Company NameGreatbatch Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Length70 Millimeter
Lumen/Inner Diameter2.6 Millimeter
Total Volume12 Milliliter
Needle Gauge18 Gauge
Length60 Centimeter
Outer Diameter2.8 Millimeter
Catheter Gauge7.5 French
Lumen/Inner Diameter0.9 Millimeter
Length14 Centimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100821329000522 [Primary]
GS110821329000529 [Package]
Contains: 00821329000522
Package: box [1 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2017-10-26

On-Brand Devices [PTFE Peelable Introducer Kit]

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