BioResorb® Macro Pore KE 19005505

GUDID 04260310344058

500-1000 µm; 5 x 0.5 ml

Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien

Synthetic bone graft

• Primary Device ID: 04260310344058
• NIH Device Record Key: cc97d4e8-d6a8-4ff9-a3b3-ca421f2c47fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioResorb® Macro Pore
• Version Model Number: KE 19005505
• Catalog Number: KE 19005505
• Company DUNS: 332192830
• Company Name: Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien
• Device Count: 1
• 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: false
• 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	04260310344058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050260

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-25

On-Brand Devices [BioResorb® Macro Pore]

• 04260310344157: 1400-3200 µm; 1 x 2.0 ml
• 04260310344140: 1400-3200 µm; 1 x 1.0 ml
• 04260310344133: 1000-2000 µm; 5 x 2.0 ml
• 04260310344126: 1000-2000 µm; 5 x 1.0 ml
• 04260310344119: 1000-2000 µm; 5 x 0.5 ml
• 04260310344102: 1000-2000 µm; 1 x 2.0 ml
• 04260310344096: 1000-2000 µm; 1 x 1.0 ml
• 04260310344089: 1000-2000 µm; 1 x 0.5 ml
• 04260310344072: 500-1000 µm; 5 x 2.0 ml
• 04260310344065: 500-1000 µm; 5 x 1.0 ml
• 04260310344058: 500-1000 µm; 5 x 0.5 ml
• 04260310344041: 500-1000 µm; 1 x 2.0 ml
• 04260310344034: 500-1000 µm; 1 x 1.0 ml
• 04260310344027: 500-1000 µm; 1 x 0.5 ml
• 04260310344010: 200-500 µm; 5 x 0.5 ml
• 04260310344003: 200-500 µm; 1 x 0.5 ml