OsteoMed 390-6003
GUDID 00842528104156
OsteoVation RM-EX Inject, Bone Void Filler, 3cc
SKELETAL KINETICS LLC
Bone matrix implant, synthetic Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 00842528104156 |
| NIH Device Record Key | ca369987-0328-4d7b-b35c-b424cc2d6003 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoMed |
| Version Model Number | 390-6003 |
| Catalog Number | 390-6003 |
| 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 | 972-677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com | |
| Phone | +1(972)677-4655 |
| cs@skeletalkinetics.com |
Device Dimensions
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842528104156 [Primary] |
FDA Product Code
| GXP | METHYL METHACRYLATE FOR CRANIOPLASTY |
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 | 2017-04-20 |
On-Brand Devices [OsteoMed]
| 00842528104156 | OsteoVation RM-EX Inject, Bone Void Filler, 3cc |
| 00842528100189 | OsteoVation RM-EX, 10cc |
| 00842528100172 | OsteoVation RM-EX, 5cc |
Trademark Results [OsteoMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOMED 97627156 not registered Live/Pending |
OsteoMed LLC 2022-10-11 |
 OSTEOMED 76379471 2766295 Live/Registered |
OSTEOMED L.P. 2002-03-06 |
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