ProModel 65-1005-S
GUDID 00813845020283
ProModel Inject 5cc
SKELETAL KINETICS LLC
Bone matrix implant, synthetic| Primary Device ID | 00813845020283 |
| NIH Device Record Key | 17886d82-d11e-4d62-9697-db6b2e9bdf1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProModel |
| Version Model Number | 65-1005-S |
| Catalog Number | 65-1005-S |
| 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 | 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 |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 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 | 00813845020283 [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 [ProModel]
| 00813845020313 | ProModel Impact 10cc |
| 00813845020306 | ProModel Impact 5cc |
| 00813845020290 | ProModel Inject 10cc |
| 00813845020283 | ProModel Inject 5cc |
| 00813845020276 | ProModel Inject 3cc |
Trademark Results [ProModel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROMODEL 85349196 4187870 Live/Registered |
Acumed LLC 2011-06-17 |
 PROMODEL 74179810 1688885 Live/Registered |
PROMODEL CORPORATION 1991-06-24 |
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