InkWell Health

GUDID 00860010334539

InkWell Health Large Right Knee Temporary Tattoo Kit

Inkwell Health Ltd

Skin marking guide, single-use

• Primary Device ID: 00860010334539
• NIH Device Record Key: 1b6c3f99-69fb-42bd-9f99-07671e68bb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InkWell Health
• Version Model Number: LGRKNEE-MTT-KIT
• Company DUNS: 243295371
• Company Name: Inkwell Health Ltd
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010334539 [Primary]
GS1	00860010334546 [Unit of Use]

FDA Product Code

• FZZ: Marker, Skin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [InkWell Health ]

• 00860010334539: InkWell Health Large Right Knee Temporary Tattoo Kit
• 00860010334522: InkWell Health Large Right Knee Temporary Tattoo
• 00860010334515: InkWell Health Large Left Knee Temporary Tattoo Kit
• 00860010334508: InkWell Health Large Left Knee Temporary Tattoo.
• 00860010334577: Large Right Knee Temporary 3 Month Kit
• 10860010334567: Large Left Knee Medial Temporary Tattoo 3 Month Kit
• 00860010334560: Large Left Knee Medial Temporary Tattoo 3 Month Kit