Primary Device ID | 07613327554496 |
NIH Device Record Key | 42cd5a5f-a519-4ec7-b442-66288ba670cb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Omnicurve |
Version Model Number | 1032-115-000 |
Catalog Number | 1032-115-000 |
Company DUNS | 196548481 |
Company Name | STRYKER CORPORATION |
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 | 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 |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Balloon Length | 15 Millimeter |
Needle Gauge | 11 Gauge |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 12 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327554496 [Primary] |
HRX | Arthroscope |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-20 |
Device Publish Date | 2022-04-12 |
07613327554700 | 11G 20mm Extra Level Kit |
07613327554687 | 11G 15mm Extra Level Kit |
07613327554663 | 11G 20mm Fracture Kit |
07613327554496 | 11G 15mm Fracture Kit |
07613327554649 | 11G 30mm Fracture Kit |
07613327554724 | 11G 30mm Fracture Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNICURVE 88577083 not registered Live/Pending |
Stryker Corporation 2019-08-13 |
OMNICURVE 73471137 1310948 Dead/Cancelled |
CooperVision, Inc. 1984-03-19 |