Super Sheath XL

GUDID 74543527202007

TOGO MEDIKIT CO.,LTD.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 74543527202007
• NIH Device Record Key: f498ee38-3a66-453e-a8c2-a50b2da24ec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super Sheath XL
• Version Model Number: (15-736B) CI11L25TP0038
• Company DUNS: 690724240
• Company Name: TOGO MEDIKIT CO.,LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, in a dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543527202008 [Primary]
GS1	14543527202005 [Package]; Contains: 04543527202008; Package: Box [1 Units]; In Commercial Distribution
GS1	74543527202007 [Package]; Contains: 14543527202005; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060190

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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-16

On-Brand Devices [Super Sheath XL]

• 74543527202021: (15-739B) CI14L25TP0038
• 14543527202012: (15-737B) CI12L25TP0038
• 74543527202007: (15-736B) CI11L25TP0038
• 14543527201992: (15-735B) CI10L25TP0038
• 74543527201987: (15-740B) CI14L11TP0038
• 14543527201978: (15-728B) CI12L11TP0038
• 14543527201961: (15-727B) CI11L11TP0038
• 74543527201956: (15-726B) CI10L11TP0038
• 74543527201949: (15-741B) CI14L11TG0035
• 74543527201932: (15-718B) CI12L11TG0035
• 14543527201923: (15-717B) CI11L11TG0035
• 14543527201916: (15-716B) CI10L11TG0035
• 14543527185308: (15-739B) CI14L25TP0038
• 14543527185292: (15-737B) CI12L25TP0038
• 14543527185285: (15-736B) CI11L25TP0038
• 14543527185278: (15-735B) CI10L25TP0038
• 14543527185261: (15-740B) CI14L11TP0038
• 74543527185256: (15-728B) CI12L11TP0038
• 14543527185247: (15-727B) CI11L11TP0038
• 14543527185230: (15-726B) CI10L11TP0038
• 14543527185223: (15-741B) CI14L11TG0035
• 74543527185218: (15-718B) CI12L11TG0035
• 14543527185209: (15-717B) CI11L11TG0035
• 74543527185195: (15-716B) CI10L11TG0035
• 14543527202029: (15-739B) CI14L25TP0038
• 14543527201947: (15-741B) CI14L11TG0035
• 14543527201930: (15-718B) CI12L11TG0035
• 14543527202005: (15-736B) CI11L25TP0038
• 14543527201985: (15-740B) CI14L11TP0038
• 14543527201954: (15-726B) CI10L11TP0038
• 14543527185254: (15-728B) CI12L11TP0038
• 14543527185216: (15-718B) CI12L11TG0035
• 14543527185193: (15-716B) CI10L11TG0035
• 74543527202014: (15-737B) CI12L25TP0038
• 14543527267004: CI14L25TP0038
• 14543527266991: CI12L25TP0038
• 14543527266984: CI11L25TP0038
• 14543527266977: CI10L25TP0038
• 14543527266960: CI14L11TP0038
• 14543527266953: CI14L11TG0035
• 14543527266946: CI12L11TP0038
• 14543527266939: CI12L11TG0035
• 14543527266922: CI11L11TP0038
• 14543527266915: CI11L11TG0035
• 14543527266908: CI10L11TP0038
• 14543527266892: CI10L11TG0035