N/A SGDH54

GUDID 00848956020402

SafeGuard Dry - Heavy - 54x54 in , 48 applications/case

HEALTHMARK INDUSTRIES CO., INC.

Sterilization packaging, single-use

• Primary Device ID: 00848956020402
• NIH Device Record Key: a1390218-620b-49a6-86bf-5769e5516c32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: SGDH54
• Catalog Number: SGDH54
• Company DUNS: 057680480
• Company Name: HEALTHMARK INDUSTRIES CO., INC.
• Device Count: 48
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848956020402 [Unit of Use]
GS1	10848956020409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230137

FDA Product Code

• FRG: Wrap, Sterilization

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: 2025-06-26
• Device Publish Date: 2025-06-18

On-Brand Devices [N/A]

• 00848956020402: SafeGuard Dry - Heavy - 54x54 in , 48 applications/case
• 00848956020396: SafeGuard Dry - Heavy - 48x48 in , 48 applications/case
• 10848956020386: SafeGuard Dry - Heavy - 45x45 in , 48 applications/case
• 10848956020379: SafeGuard Dry - Heavy - 40x40 in , 72 applications/case
• 10848956020362: SafeGuard Dry - Heavy - 36x36 in , 72 applications/case
• 10848956020355: SafeGuard Dry - Heavy - 24x24 in , 120 applications/case