SKaffold SKMX-IM10
GUDID 00813845020924
Skaffold Impress (MX), 10cc
SKELETAL KINETICS LLC
Bone matrix implant, synthetic| Primary Device ID | 00813845020924 |
| NIH Device Record Key | 6b6fb8c7-2bf2-4a6d-a282-28f457d0bb79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SKaffold |
| Version Model Number | SKMX-IM10 |
| Catalog Number | SKMX-IM10 |
| Company DUNS | 140071411 |
| Company Name | SKELETAL KINETICS LLC |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com | |
| Phone | +1(408)366-5014 |
| cs@skeletalkinetics.com |
Device Dimensions
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813845020924 [Primary] |
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 | 4 |
| Public Version Date | 2018-06-29 |
| Device Publish Date | 2015-10-30 |
On-Brand Devices [SKaffold]
| 00813845020924 | Skaffold Impress (MX), 10cc |
| 00813845020917 | Skaffold Impress (MX), 5cc |
| 00813845020900 | Skaffold Flow (MX), 10cc |
| 00813845020894 | Skaffold Flow (MX), 5cc |
| 00813845020887 | Skaffold Flow (MX), 3cc |
| 00813845020801 | Skaffold Impress 25cc |
| 00813845020795 | Skaffold Impress 10cc |
| 00813845020788 | Skaffold Impress 5cc |
| 00813845020771 | Skaffold Flow 10cc |
| 00813845020764 | Skaffold Flow 5cc |
| 00813845020733 | Skaffold CMF Impress (MX), 10cc |
| 00813845020726 | Skaffold CMF Impress (MX), 5cc |
| 00813845020719 | Skaffold CMF Flow (MX), 10cc |
| 00813845020702 | Skaffold CMF Flow (MX), 5cc |
| 00813845020696 | Skaffold CMF Impress (MP), 10cc |
| 00813845020689 | Skaffold CMF Impress (MP), 5cc |
Trademark Results [SKaffold]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKAFFOLD 77734285 3832806 Live/Registered |
Skeletal Kinetics LLC 2009-05-11 |
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