THERA Plus

GUDID 00049696186773

Lancets 200CT

FOURSTAR GROUP INC.

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