Bionnovation

GUDID 07908854001453

Bionnovation Installation

ANDRE GREGATE BRAGA INSTRUMENTOS LTDA

Surgical screwdriver, reusable

• Primary Device ID: 07908854001453
• NIH Device Record Key: cd852e0d-f050-495b-89ca-d9f5f368ba4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionnovation
• Version Model Number: 13127
• Company DUNS: 921478697
• Company Name: ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
• 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: false
• Lot Batch: true
• Serial Number: false
• 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	07908854001453 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

[07908854001453]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

Devices Manufactured by ANDRE GREGATE BRAGA INSTRUMENTOS LTDA

• 07908854001668 - Supremo Instrumentos: 2025-10-07 Broca LRS1
• 07908854001675 - Supremo Instrumentos: 2025-10-07 Broca RRS2
• 07908854001453 - Bionnovation: 2025-04-25Bionnovation Installation
• 07908854001453 - Bionnovation: 2025-04-25 Bionnovation Installation
• 07908854000876 - Supremo Instrumentos: 2025-04-24 Cabo Bisturi Redondo Reto Cabo S
• 07908854001125 - Supremo Instrumentos: 2025-04-24 Micro Forceps Atraumatica reta
• 07908854001149 - Supremo Instrumentos: 2025-04-24 P.A. Castroviejo 18cm Reto GOLD
• 07908854001385 - Supremo Instrumentos: 2025-04-24 DESCOLADOR JB
• 07908854001392 - Supremo Instrumentos: 2025-04-24 CURETA N14