SA-C-FB4L

GUDID 00840240937618

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use

• Primary Device ID: 00840240937618
• NIH Device Record Key: b0717219-e015-45c5-8ab6-0272fd62e30c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SA-C-FB4L
• Version Model Number: SA-C-FB4L
• 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	00840240937618 [Secondary]
HIBCC	M944SACFB4L0 [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.

• 00840240938202 - Wexler Surgical, Inc.: 2025-09-01
• 00840240938219 - Wexler Surgical, Inc.: 2025-09-01
• 00840240938226 - Wexler Surgical, Inc.: 2025-09-01
• 00840240938127 - Wexler Surgical, Inc.: 2025-05-26
• 00840240938110 - Wexler Surgical, Inc.: 2025-05-26
• 00840240938103 - Wexler Surgical, Inc.: 2025-05-26
• 00840240938097 - Wexler Surgical, Inc.: 2025-05-26
• 00840240938066 - Wexler Surgical, Inc.: 2025-04-07