THERA Plus

GUDID 00049696186773

Lancets 200CT

FOURSTAR GROUP INC.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 00049696186773
• NIH Device Record Key: b68d1037-6ca4-4490-a645-5d1c1a4d170a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERA Plus
• Version Model Number: 64431942AA
• Company DUNS: 656091279
• Company Name: FOURSTAR GROUP INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00049696186773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222472

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

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

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

[00049696186773]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-06
• Device Publish Date: 2023-10-27

On-Brand Devices [THERA Plus]

• 00049696299923: "THERA DIGITAL THERMOMETER FLEXIBLE 1 CT "
• 00049696507806: TP THERAPY ICE BAG
• 00049696507790: TP HEAT PATCH AIR ACTIVATED 1CT
• 00049696187886: WOMEN'S UNDERWEAR 10CT_L-XL
• 00049696187879: MEN'S UNDERWEAR 10CT_L-XL
• 00049696187206: MEN'S UNDERWEAR 10CT_S-M
• 00049696187183: WOMEN'S UNDERWEAR 10CT_S-M
• 00049696186797: Lancing Device 1CT
• 00049696186773: Lancets 200CT
• 00049696895965: ADVANCED HEALING BLISTER HEEL BANDAGES
• 00049696895927: ADVANCED HEALING GEL HEEL BANDAGES