Synthacer/Syntricer 6.2/7.2G01

GUDID 04250971421816

Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 20 ml

medArtis Medizinprodukte und Forschung Aktiengesellschaft

Bone matrix implant, synthetic

• Primary Device ID: 04250971421816
• NIH Device Record Key: fae6fa25-beaa-4cb2-ad50-514712cbaa11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthacer/Syntricer
• Version Model Number: T672G01-20-1
• Catalog Number: 6.2/7.2G01
• Company DUNS: 313163545
• Company Name: medArtis Medizinprodukte und Forschung Aktiengesellschaft
• 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: 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 Dimensions

• Pore Size: 600 Micrometer
• Total Volume: 20 Milliliter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250971421816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041177

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2015-10-24

On-Brand Devices [Synthacer/Syntricer]

• 04250971422097: Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 3 ml
• 04250971422080: Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 2 ml
• 04250971422073: Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 1 ml
• 04250971422066: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 5 ml
• 04250971422059: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 2 ml
• 04250971422042: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 3 mm, 1 ml
• 04250971422035: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
• 04250971422028: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
• 04250971422011: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
• 04250971422004: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, mixture with diameters 4 mm and 6
• 04250971421991: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 6 mm, 10 ml
• 04250971421984: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 6 mm, 5 ml
• 04250971421977: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 4 mm, 10 ml
• 04250971421960: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 30 ml
• 04250971421953: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 20 ml
• 04250971421946: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 15 ml
• 04250971421939: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 10 ml
• 04250971421922: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 5 ml
• 04250971421915: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 2 ml
• 04250971421908: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 2.6 - 4.8 mm, 1 ml
• 04250971421892: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 30 ml
• 04250971421885: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 20 ml
• 04250971421878: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 15 ml
• 04250971421861: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 10 ml
• 04250971421854: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 5 ml
• 04250971421847: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 2 ml
• 04250971421830: Synthacer®/Synthacer® 600 granules, mixture of HA and TCP, particle size 1.0 - 2.5 mm, 1 ml
• 04250971421823: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 30 ml
• 04250971421816: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 20 ml
• 04250971421809: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 15 ml
• 04250971421793: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 10 ml
• 04250971421786: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 5 ml
• 04250971421779: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 2 ml
• 04250971421762: Synthacer®/Synthacer® 600 powder, mixture of HA and TCP, particle size 0.1 - 0.9 mm, 1 ml
• 04250971401412: Synthacer®/Syntricer® 300 Ceraball®, mixture of HA and TCP, diameter 1.5 mm, 0.5 ml
• 04250971400705: Synthacer®/Syntricer® 600 Ceraball®, mixture of HA and TCP, diameter 4 mm, 5 ml