Sterilization Tray

GUDID 08404535019520

BR-9708K

Peter Brasseler Holdings, LLC

Instrument tray, reusable

• Primary Device ID: 08404535019520
• NIH Device Record Key: 6442c9db-07fd-4474-8744-a7faae419e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Tray
• Version Model Number: BR-9708K
• Company DUNS: 082080136
• Company Name: Peter Brasseler Holdings, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08404535019520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983223

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

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

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

[08404535019520]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-18
• Device Publish Date: 2025-08-09

Devices Manufactured by Peter Brasseler Holdings, LLC

• 08404535019520 - Sterilization Tray: 2025-08-18BR-9708K
• 08404535019520 - Sterilization Tray: 2025-08-18 BR-9708K
• 08404535019278 - Axiom Blades: 2025-08-05 BRAXM-FL6LH
• 08404535019308 - Axiom Blades: 2025-08-05 BRAXM-EXT
• 08404535015539 - Axiom Blades: 2025-06-09 BRAXM-HS6S
• 08404535015560 - Axiom Blades: 2025-06-09 BRAXM-FS6S
• 08404535015591 - Axiom Blades: 2025-06-09 BRAXM-HS6M
• 08404535015621 - Axiom Blades: 2025-06-09 BRAXM-FS6M
• 08404535015652 - Axiom Blades: 2025-06-09 BRAXM-FS8S