SA-FB5

GUDID 00840240937564

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use

• Primary Device ID: 00840240937564
• NIH Device Record Key: 7f1b2c13-cad2-4b5a-ad55-e7adf1ea4498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SA-FB5
• Version Model Number: SA-FB5
• Company DUNS: 024882552
• Company Name: WEXLER SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840240937564 [Secondary]
HIBCC	M944SAFB50 [Primary]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

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: 2025-02-24
• Device Publish Date: 2025-02-14

Devices Manufactured by WEXLER SURGICAL, INC.

• 00840240937618 - SA-C-FB4L: 2025-02-24
• 00840240937571 - SA-C-FB5: 2025-02-24
• 00840240937557 - SA-DB1L: 2025-02-24
• 00840240937533 - SA-DB2L: 2025-02-24
• 00840240937649 - SA-DB3: 2025-02-24
• 00840240937625 - SA-DB3L: 2025-02-24
• 00840240937656 - SA-DB4: 2025-02-24
• 00840240937632 - SA-DB4L: 2025-02-24