Norian 07704103S
GUDID H67907704103S0
NORIAN DRILLABLE FAST SET PUTTY 3CC-STERILE
Synthes GmbH
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 Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | H67907704103S0 |
| NIH Device Record Key | a6c1395b-1a63-4844-af96-dc114d79a0e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Norian |
| Version Model Number | 07.704.103S |
| Catalog Number | 07704103S |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 43 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982131638 [Primary] |
| HIBCC | H67907704103S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073303
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 | 5 |
| Public Version Date | 2022-04-29 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [Norian]
| H67907704110S0 | NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE |
| H67907704105S0 | NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE |
| H67907704103S0 | NORIAN DRILLABLE FAST SET PUTTY 3CC-STERILE |
| H67907704010S0 | NORIAN DRILLABLE INJECT 10CC-STERILE |
| H67907704005S0 | NORIAN DRILLABLE INJECT 5CC-STERILE |
| H67907704003S0 | NORIAN DRILLABLE INJECT 3CC-STERILE |
Trademark Results [Norian]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NORIAN 77471661 3928905 Dead/Cancelled |
Ingen Software, Inc. 2008-05-12 |
 NORIAN 75229611 2171951 Live/Registered |
Norian Corporation 1997-01-22 |
 NORIAN 75068191 2037064 Live/Registered |
Norian Corporation 1996-03-06 |
 NORIAN 74264424 1943070 Live/Registered |
Norian Corporation 1992-04-10 |
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