SV BOLSTER LARGE SP2555

GUDID 00856525007143

SAPHENOUS VEIN COMPRESSION FOAM DRESSING WITH AIR BOLSTER LARGE

SUN SCIENTIFIC, INC.

Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial

• Primary Device ID: 00856525007143
• NIH Device Record Key: 4e45222b-9d41-463b-b392-e2dbceb96751
• Commercial Distribution Discontinuation: 2025-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SV BOLSTER LARGE
• Version Model Number: SP2555
• Catalog Number: SP2555
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070457

FDA Product Code

• MHW: Dressing, Compression
• NAC: Dressing, Wound, Hydrophilic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-04
• Device Publish Date: 2022-04-26

Devices Manufactured by SUN SCIENTIFIC, INC.

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• 00850051939312 - Aero-Wrap® Arm: 2024-02-26 The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compr
• 00850051939329 - Aero-Wrap® Arm: 2024-02-26 The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compr
• 00850051939336 - Aero-Wrap® Arm: 2024-02-26 The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compr
• 00850051939343 - Aero-Wrap® Arm: 2024-02-26 The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compr
• 00850051939350 - Aero-Wrap® Arm: 2024-02-26 The Aero-Wrap® Arm, System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compr
• 00850051939282 - AeroWrap Extension Panel small/medium: 2024-02-06 An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compres
• 00850051939299 - AeroWrap Extension Panel Large/XLarge: 2024-02-06 An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compres