PTFE Peelable Introducer Kit 7091

GUDID 10821329400671

Greatbatch Ltd

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10821329400671
• NIH Device Record Key: ebc6699b-98df-4b13-9f9e-58b03a45ebc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTFE Peelable Introducer Kit
• Version Model Number: 667091-304
• Catalog Number: 7091
• Company DUNS: 968623467
• Company Name: Greatbatch Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 60 Centimeter
• Outer Diameter: 0.89 Millimeter
• Length: 14.2 Centimeter
• Lumen/Inner Diameter: 2.7 Millimeter
• Outer Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 0.9 Millimeter
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821329400674 [Primary]
GS1	10821329400671 [Package]; Contains: 00821329400674; Package: box [1 Units]; In Commercial Distribution

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-09-24

On-Brand Devices [PTFE Peelable Introducer Kit]

• 00802526579134: 7088
• 00802526579127: 7087
• 00802526555343: 7127
• 00802526555336: 7095
• 00802526555329: 7093
• 00802526555312: 7091
• 00802526555305: 7089
• 00802526527937: 667133-303
• 00802526527920: 667131-303
• 00802526527913: 667129-303
• 00802526527906: 667127-303
• 00802526527890: 667099-303
• 00802526527883: 667097-303
• 00802526527876: 667096-303
• 00802526527869: 667095-303
• 00802526527852: 667093-303
• 00802526527845: 667091-303
• 00802526527838: 667090-303
• 00802526527821: 667089-303
• 00802526527814: 667088-303
• 00802526527807: 667087-303
• 00802526486128: 7142
• 00802526486111: 7092
• 10821329601511: 667127-351
• 10821329400725: 667099-304
• 10821329400718: 667097-304
• 10821329400701: 667096-304
• 10821329400695: 667095-304
• 10821329400688: 667093-304
• 10821329400671: 667091-304
• 10821329400664: 667090-304
• 10821329400657: 667089-304
• 10821329400640: 667088-304
• 10821329400633: 667133-304
• 10821329400626: 667131-304
• 10821329400619: 667129-304
• 10821329400602: 667127-304
• 00821329001628: 667097-402
• 00821329001611: 667095-402
• 00821329001604: 667093-402
• 00821329001598: 667091-402
• 00821329001581: 667089-402
• 00821329001574: 667087-402
• 10821329001212: 10383-010
• 10821329001205: 10383-009
• 10821329001199: 10383-008
• 10821329001182: 10383-007
• 10821329001175: 10383-006
• 10821329001168: 10383-004
• 10821329001151: 10383-003