SHERPA NX BALANCED

GUDID 20613994846444

CATHETER SB6JL505 SB 6F 5PK 100CM JL50

MEDTRONIC, INC.

Vascular guide-catheter, single-use
Primary Device ID20613994846444
NIH Device Record Keyab4a829d-2e9d-4c9b-8fb3-169552b8af21
Commercial Distribution Discontinuation2017-08-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSHERPA NX BALANCED
Version Model NumberSB6JL505
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length100 Centimeter
Length100 Centimeter
Length100 Centimeter
Length100 Centimeter
Length100 Centimeter
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length100 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994846440 [Primary]
GS120613994846444 [Package]
Contains: 00613994846440
Package: PK [5 Units]
Discontinued: 2017-08-02
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-06-12

On-Brand Devices [SHERPA NX BALANCED]

00613994905314CATHETER SB6PAPA1 SB 6F 100CM PAPA1
00613994905307CATHETER SB6PAPA SB 6F 100CM PAPA
00613994846457CATHETER SB7AR20A SB 7F 110CM AR20
20613994846444CATHETER SB6JL505 SB 6F 5PK 100CM JL50
00613994842428CATHETER SB7LCBA SB 7F 110CM LCB
00613994842411CATHETER SB7JR40A SB 7F 110CM JR40
00613994842404CATHETER SB7JL40A SB 7F 110CM JL40
00613994842398CATHETER SB7AL20A SB 7F 110CM AL20
00613994837776CATHETER SB7EBUL35 SB 7F 100CM EL35
00613994837769CATHETER SB7EBUL35SH SB 7F 100CM EL35
00613994837752CATHETER SB7EBUL375 SB 7F 100CM EL375
00613994837745CATHETER SB7EBUL375SH SB 7F 100CM EL375
00613994837738CATHETER SB7EBUL40 SB 7F 100CM EL40
00613994837721CATHETER SB7EBUL40SH SB 7F 100CM EL40
00613994837714CATHETER SB7EBUL45 SB 7F 100CM EL45
00613994837707CATHETER SB7EBUL45SH SB 7F 100CM EL45
00613994837691CATHETER SB7EBUL50 SB 7F 100CM EL50
00613994837684CATHETER SB7EBUL50SH SB 7F 100CM EL50
00613994837677CATHETER SB7ECR35 SB 7F 100CM ECR35
00613994837660CATHETER SB7ECR35SH SB 7F 100CM ECR35
00613994837653CATHETER SB7ECR40 SB 7F 100CM ECR40
00613994837646CATHETER SB7ECR40SH SB 7F 100CM ECR40
00613994837639CATHETER SB7ECR45 SB 7F 100CM ECR45
00613994837622CATHETER SB7ECR45SH SB 7F 100CM ECR45
00613994837615CATHETER SB7ELGAMAL SB 7F 100CM EG
00613994837608CATHETER SB7EBUL30SH SB 7F 100CM EL30
00613994837592CATHETER SB7EBU35 SB 7F 100CM EB35
20613994837589CATHETER SB7EBU355 SB 7F 100CM 5PK EB35
00613994837578CATHETER SB7EBU35SH SB 7F 100CM EB35
00613994837561CATHETER SB7EBU35SHD SB 7F 90CM EB35
00613994837554CATHETER SB7EBU375 SB 7F 100CM EB375
00613994837547CATHETER SB7EBU375SH SB 7F 100CM EB375
00613994837530CATHETER SB7EBU375SHD SB 7F 90CM EB375
00613994837523CATHETER SB7EBU40 SB 7F 100CM EB40
20613994837510CATHETER SB7EBU405 SB 7F 100CM 5PK EB40
00613994837509CATHETER SB7EBU40D SB 7F 90CM EB40
00613994837493CATHETER SB7EBU40SH SB 7F 100CM EB40
00613994837486CATHETER SB7EBU45 SB 7F 100CM EB45
20613994837473CATHETER SB7EBU455 SB 7F 100CM 5PK EB45
00613994837462CATHETER SB7EBU45SH SB 7F 100CM EB45
00613994837455CATHETER SB7EBU50 SB 7F 100CM EB50
00613994837448CATHETER SB7EBU50SH SB 7F 100CM EB50
00613994837431CATHETER SB7EBUL30 SB 7F 100CM EL30
00613994837424CATHETER SB7IMT SB 7F 100CM IMT
00613994837417CATHETER SB7JCL30 SB 7F 100CM JCL30
00613994837400CATHETER SB7JCL30SH SB 7F 100CM JCL30
00613994837394CATHETER SB7JCL35 SB 7F 100CM JCL35
00613994837387CATHETER SB7JCL35SH SB 7F 100CM JCL35
00613994837370CATHETER SB7JCL40 SB 7F 100CM JCL40
00613994837363CATHETER SB7JCL40SH SB 7F 100CM JCL40

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