GRAFTYS® QUICKSET GYQSMUSV1Q5
GUDID 03760177571600
Injectable Macroporous Calcium Phosphate
GRAFTYS
Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 03760177571600 |
| NIH Device Record Key | dcde6816-0131-4ea4-986d-66c9eceb5b67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GRAFTYS® QUICKSET |
| Version Model Number | 5cc |
| Catalog Number | GYQSMUSV1Q5 |
| Company DUNS | 280930053 |
| Company Name | GRAFTYS |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760177571600 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093343
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-28 |
| Device Publish Date | 2024-03-20 |
On-Brand Devices [GRAFTYS® QUICKSET]
| 03760177571624 | Injectable Macroporous Calcium Phosphate |
| 03760177571617 | Injectable Macroporous Calcium Phosphate |
| 03760177571600 | Injectable Macroporous Calcium Phosphate |
Trademark Results [GRAFTYS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GRAFTYS 79190947 5440313 Live/Registered |
GRAFTYS 2016-06-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.