Tenderlett Finger Incision Device TL5000I

GUDID 20711234308186

Tenderlett Finger Incision Device 5000/box

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

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• Primary Device ID: 20711234308186
• NIH Device Record Key: cb864bdc-fe34-4d43-8a0f-fd7f7dd25971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenderlett Finger Incision Device
• Version Model Number: TL5000I
• Catalog Number: TL5000I
• Company DUNS: 079299318
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Device Count: 5000
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Customer Support Contacts

• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-643-1640
• Email: UDI@accriva.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com
• Phone: 1-800-678-0710
• Email: ilsd_ra.na@werfen.com

Device Dimensions

• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter
• Length: 0.94 Millimeter
• Depth: 1.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711234308182 [Unit of Use]
GS1	20711234308186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923302

FDA Product Code

• FMK: Lancet, Blood

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: 2018-11-19
• Device Publish Date: 2016-09-22

On-Brand Devices [Tenderlett Finger Incision Device]

• 20711234308186: Tenderlett Finger Incision Device 5000/box
• 20711234308162: Tenderlett Finger Incision Device 100/box