Syntricer 7.N2G03

GUDID 04250971406714

Syntricer® 600 granules, "negative", TCP, particle size 2.6 - 4.8 mm

medArtis Medizinprodukte und Forschung Aktiengesellschaft

Bone matrix implant, synthetic

• Primary Device ID: 04250971406714
• NIH Device Record Key: 8b4228f8-0151-40b0-895b-d3f1b8462892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntricer
• Version Model Number: T7N2G03-1
• Catalog Number: 7.N2G03
• 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

• Device Size Text, specify: 0
• Pore Size: 600 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250971406714 [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 [Syntricer]

• 04250971421755: Syntricer® 300 Ceraball®, TCP, diameter 1.5 mm, 3 ml
• 04250971421748: Syntricer® 300 Ceraball®, TCP, diameter 1.5 mm, 2 ml
• 04250971421731: Syntricer® 300 Ceraball®, TCP, diameter 1.5 mm, 1 ml
• 04250971421724: Syntricer® 600 Ceraball®, TCP, diameter 3 mm, 5 ml
• 04250971421717: Syntricer® 600 Ceraball®, TCP, diameter 3 mm, 2 ml
• 04250971421700: Syntricer® 600 Ceraball®, TCP, mixture with diameters 4 mm and 6 mm, 30 ml
• 04250971421694: Syntricer® 600 Ceraball®, TCP, mixture with diameters 4 mm and 6 mm, 20 ml
• 04250971421687: Syntricer® 600 Ceraball®, TCP, mixture with diameters 4 mm and 6 mm, 10 ml
• 04250971421670: Syntricer® 600 Ceraball®, TCP, diameter 6 mm, 10 ml
• 04250971421663: Syntricer® 600 Ceraball®, TCP, diameter 4 mm, 10 ml
• 04250971420345: Syntricer® 1000 granules, TCP, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420338: Syntricer® 1000 granules, TCP, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420321: Syntricer® 1000 granules, TCP, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420314: Syntricer® 1000 granules, TCP, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420307: Syntricer® 1000 powder, TCP, particle size 0.1 - 0.9 mm, 2 ml
• 04250971420291: Syntricer® 1000 powder, TCP, particle size 0.1 - 0.9 mm, 1 ml
• 04250971420284: Syntricer® 300 granules, TCP, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420277: Syntricer® 300 granules, TCP, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420260: Syntricer® 300 granules, TCP, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420253: Syntricer® 300 granules, TCP, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420246: Syntricer® 300 powder, TCP, particle size 0.1 - 0.9 mm, 2 ml
• 04250971420239: Syntricer® 300 powder, TCP, particle size 0.1 - 0.9 mm, 1 ml
• 04250971420222: Syntricer® 600 granules, TCP, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420215: Syntricer® 600 granules, TCP, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420208: Syntricer® 600 granules, TCP, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420192: Syntricer® 600 granules, TCP, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420185: Syntricer® 600 powder, TCP, particle size 0.1 - 0.9 mm, 2 ml
• 04250971420178: Syntricer® 600 powder, TCP, particle size 0.1 - 0.9 mm, 1 ml
• 04250971407988: Syntricer® 1000 Ceraball®, "negative", TCP, diameter 3 mm
• 04250971407971: Syntricer® 1000 Ceraball®, "negative", TCP, mixture with diameters 4 mm and 6 mm
• 04250971407964: Syntricer® 1000 Ceraball®, "negative", TCP, diameter 6 mm
• 04250971407957: Syntricer® 1000 Ceraball®, "negative", TCP, diameter 4 mm
• 04250971407940: Syntricer® 1000 rounded granules Ceround®, "negative", TCP, particle size 2.6 - 4.8 mm
• 04250971407933: Syntricer® 1000 granules, "negative", TCP, particle size 2.6 - 4.8 mm
• 04250971407926: Syntricer® 1000 rounded granules Ceround®, "negative", TCP, particle size 1.0 - 2.5 mm
• 04250971407919: Syntricer® 1000 granules, "negative", TCP, particle size 1.0 - 2.5 mm
• 04250971407902: Syntricer® 1000 powder, "negative", TCP, particle size 0.1 - 0.9 mm
• 04250971407858: Syntricer® 1000 wedge, "negative", TCP, 30 x 22 x 13 mm
• 04250971407841: Syntricer® 1000 wedge, "negative", TCP, 30 x 22 x 11 mm
• 04250971407834: Syntricer® 1000 wedge, "negative", TCP, 30 x 22 x 9 mm
• 04250971407810: Syntricer® 1000 block, "negative", TCP, 20 x 20 x 15 mm
• 04250971407803: Syntricer® 1000 block, "negative", TCP, 10 x 10 x 15 mm
• 04250971407797: Syntricer® 1000 block, "negative", TCP, 5 x 5 x 15 mm
• 04250971407766: Syntricer® 1000 cylinder, "negative", TCP, size 17, diameter 21.15 mm, length 25 mm, without li
• 04250971407759: Syntricer® 1000 cylinder, "negative", TCP, size 17, diameter 21.15 mm, length 25 mm, with lid
• 04250971407742: Syntricer® 1000 cylinder, "negative", TCP, size 16, diameter 19.95 mm, length 25 mm, without li
• 04250971407735: Syntricer® 1000 cylinder, "negative", TCP, size 16, diameter 19.95 mm, length 25 mm, with lid
• 04250971407728: Syntricer® 1000 cylinder, "negative", TCP, size 15, diameter 18.75 mm, length 25 mm, without li
• 04250971407711: Syntricer® 1000 cylinder, "negative", TCP, size 15, diameter 18.75 mm, length 25 mm, with lid
• 04250971407704: Syntricer® 1000 cylinder, "negative", TCP, size 14, diameter 17.55 mm, length 25 mm, without li