Foredom

GUDID 00098666032336

Foredom powered 66" flexible shaft machine, includes Hand-held Massager Handpiece.

Foredom Electric Co

Hand-held electric massager

• Primary Device ID: 00098666032336
• NIH Device Record Key: f3fbe94d-4e83-412d-8e45-fbc918b05e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foredom
• Version Model Number: K.500L
• Company DUNS: 048343438
• Company Name: Foredom Electric Co
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: true

Customer Support Contacts

• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com
• Phone: 203-792-8622
• Email: customerservice@blackstoneind.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00098666032336 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2023-09-07
• Device Publish Date: 2023-08-30

On-Brand Devices [Foredom]

• 00098666028612: Hand-held Massager Handpiece used with Foredom powered flexible shaft machine.
• 00098666032336: Foredom powered 66" flexible shaft machine, includes Hand-held Massager Handpiece.
• 00098666032305: Foredom powered 39" flexible shaft machine, includes Hand-held Massager Handpiece.