Synthacer 6.116TMO

GUDID 04250971401054

Synthacer® 300 cylinder, HA, size 16, diameter 19.95 mm, length 25 mm, without lid

medArtis Medizinprodukte und Forschung Aktiengesellschaft

Bone matrix implant, synthetic

• Primary Device ID: 04250971401054
• NIH Device Record Key: bd7a181b-5120-48b7-b78c-ee607a345463
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthacer
• Version Model Number: T6116TMO-1
• Catalog Number: 6.116TMO
• 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: 300 Micrometer
• Outer Diameter: 19.95 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250971401054 [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]

• 04250971421656: Synthacer® 300 Ceraball®, HA, diameter 1.5 mm, 3 ml
• 04250971421649: Synthacer® 300 Ceraball®, HA, diameter 1.5 mm, 2 ml
• 04250971421632: Synthacer® 300 Ceraball®, HA, diameter 1.5 mm, 1 ml
• 04250971421625: Synthacer® 600 Ceraball®, HA, diameter 3 mm, 5 ml
• 04250971421618: Synthacer® 600 Ceraball®, HA, diameter 3 mm, 2 ml
• 04250971421601: Synthacer® 600 Ceraball®, HA, mixture with diameters 4 mm and 6 mm, 30 ml
• 04250971421595: Synthacer® 600 Ceraball®, HA, mixture with diameters 4 mm and 6 mm, 20 ml
• 04250971421588: Synthacer® 600 Ceraball®, HA, mixture with diameters 4 mm and 6 mm, 10 ml
• 04250971421571: Synthacer® 600 Ceraball®, HA, diameter 6 mm, 10 ml
• 04250971421564: Synthacer® 600 Ceraball®, HA, diameter 4 mm, 10 ml
• 04250971420161: Synthacer® 1000 granules, HA, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420154: Synthacer® 1000 granules, HA, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420147: Synthacer® 1000 granules, HA, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420130: Synthacer® 1000 granules, HA, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420123: Synthacer® 1000 powder, HA, particle size 0.1 - 0.9 mm, 2 ml
• 04250971420116: Synthacer® 1000 powder, HA, particle size 0.1 - 0.9 mm, 1 ml
• 04250971420109: Synthacer® 300 granules, HA, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420093: Synthacer® 300 granules, HA, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420086: Synthacer® 300 granules, HA, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420079: Synthacer® 300 granules, HA, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420062: Synthacer® 300 powder, HA, particle size 0.1 - 0.9 mm, 2 ml
• 04250971420055: Synthacer® 300 powder, HA, particle size 0.1 - 0.9 mm, 1 ml
• 04250971420048: Synthacer® 600 granules, HA, particle size 2.6 - 4.8 mm, 2 ml
• 04250971420031: Synthacer® 600 granules, HA, particle size 2.6 - 4.8 mm, 1 ml
• 04250971420024: Synthacer® 600 granules, HA, particle size 1.0 - 2.5 mm, 2 ml
• 04250971420017: Synthacer® 600 granules, HA, particle size 1.0 - 2.5 mm, 1 ml
• 04250971420000: Synthacer® 600 powder, HA, particle size 0.1 - 0.9 mm, 2 ml
• 04250971419998: Synthacer® 600 powder, HA, particle size 0.1 - 0.9 mm, 1 ml
• 04250971403997: Synthacer® 1000 Ceraball®, "negative", HA, diameter 3 mm
• 04250971403980: Synthacer® 1000 Ceraball®, "negative", HA, mixture with diameters 4 mm and 6 mm
• 04250971403973: Synthacer® 1000 Ceraball®, "negative", HA, diameter 6 mm
• 04250971403966: Synthacer® 1000 Ceraball®, "negative", HA, diameter 4 mm
• 04250971403959: Synthacer® 1000 rounded granules Ceround®, "negative", HA, particle size 2.6 - 4.8 mm
• 04250971403942: Synthacer® 1000 granules, "negative", HA, particle size 2.6 - 4.8 mm
• 04250971403935: Synthacer® 1000 rounded granules Ceround®, "negative", HA, particle size 1.0 - 2.5 mm
• 04250971403928: Synthacer® 1000 granules, "negative", HA, particle size 1.0 - 2.5 mm
• 04250971403911: Synthacer® 1000 powder, "negative", HA, particle size 0.1 - 0.9 mm
• 04250971403867: Synthacer® 1000 wedge, "negative", HA, 30 x 22 x 13 mm
• 04250971403850: Synthacer® 1000 wedge, "negative", HA, 30 x 22 x 11 mm
• 04250971403843: Synthacer® 1000 wedge, "negative", HA, 30 x 22 x 9 mm
• 04250971403829: Synthacer® 1000 block, "negative", HA, 20 x 20 x 15 mm
• 04250971403812: Synthacer® 1000 block, "negative", HA, 10 x 10 x 15 mm
• 04250971403805: Synthacer® 1000 block, "negative", HA, 5 x 5 x 15 mm
• 04250971403775: Synthacer® 1000 cylinder, "negative", HA, size 17, diameter 21.15 mm, length 25 mm, without lid
• 04250971403768: Synthacer® 1000 cylinder, "negative", HA, size 17, diameter 21.15 mm, length 25 mm, with lid
• 04250971403751: Synthacer® 1000 cylinder, "negative", HA, size 16, diameter 19.95 mm, length 25 mm, without lid
• 04250971403744: Synthacer® 1000 cylinder, "negative", HA, size 16, diameter 19.95 mm, length 25 mm, with lid
• 04250971403737: Synthacer® 1000 cylinder, "negative", HA, size 15, diameter 18.75 mm, length 25 mm, without lid
• 04250971403720: Synthacer® 1000 cylinder, "negative", HA, size 15, diameter 18.75 mm, length 25 mm, with lid
• 04250971403713: Synthacer® 1000 cylinder, "negative", HA, size 14, diameter 17.55 mm, length 25 mm, without lid