PTFE Peelable Introducer Kit 7127

GUDID 10821329400602

Greatbatch Ltd

Vascular catheter introduction set, nonimplantable

Primary Device ID	10821329400602
NIH Device Record Key	fc8f97ff-967a-410a-baf4-6140611ecf4d
Commercial Distribution Status	In Commercial Distribution
Brand Name	PTFE Peelable Introducer Kit
Version Model Number	667127-304
Catalog Number	7127
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	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 French
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	25 Centimeter
Lumen/Inner Diameter	3.1 Millimeter
Outer Diameter	3.2 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	9 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	00821329400605 [Primary]
GS1	10821329400602 [Package] Contains: 00821329400605 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
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10821329400626	667131-304
10821329400619	667129-304
10821329400602	667127-304
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00821329001598	667091-402
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00821329001574	667087-402
10821329001212	10383-010
10821329001205	10383-009
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10821329001182	10383-007
10821329001175	10383-006
10821329001168	10383-004
10821329001151	10383-003