Steri-Shield 0424-655-000
GUDID 07613327625158
8 Charger
STRYKER CORPORATION
Surgical helmet system| Primary Device ID | 07613327625158 |
| NIH Device Record Key | bdb21324-596c-47c4-baad-14df37b01655 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Steri-Shield |
| Version Model Number | 0424655000 |
| Catalog Number | 0424-655-000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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)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 | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327625158 [Primary] |
FDA Product Code
| LYU | ACCESSORY, SURGICAL APPAREL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2025-02-21 |
On-Brand Devices [Steri-Shield]
| 37613327625487 | 8 Tie Back Toga with Peel Away Face Shield |
| 37613327625470 | 8 Tie Back Toga with Peel Away Face Shield |
| 37613327625463 | 8 Tie Back Toga with Anti-Reflective Face Shield |
| 37613327625456 | 8 Tie Back Toga with Anti-Reflective Face Shield |
| 37613327625449 | 8 Tie Back Toga with Anti-Reflective Face Shield |
| 37613327625432 | 8 Tie Back Toga with Peel Away Face Shield |
| 37613327625425 | 8 Tie Back Toga with Peel Away Face Shield |
| 37613327625418 | 8 Tie Back Toga with Anti-Reflective Face Shield |
| 37613327625401 | 8 Tie Back Toga, Standard |
| 37613327625395 | 8 Tie Back Toga, Standard |
| 37613327625388 | 8 Tie Back Toga, Standard |
| 37613327625371 | 8 Tie Back Toga, Standard |
| 37613327625364 | 8 Zippered Toga with Anti-Reflective Face Shield |
| 37613327625357 | 8 Zippered Toga with Anti-Reflective Face Shield |
| 37613327625340 | 8 Zippered Toga with Anti-Reflective Face Shield |
| 37613327625333 | 8 Zippered Toga with Anti-Reflective Face Shield |
| 37613327625326 | 8 Pullover Toga with Anti-Reflective Face Shield |
| 37613327625319 | 8 Zippered Toga with Peel Away Face Shield |
| 37613327625302 | 8 Zippered Toga with Peel Away Face Shield |
| 37613327625296 | 8 Zippered Toga with Peel Away Face Shield |
| 37613327625289 | 8 Pullover Toga with Anti-Reflective Face Shield |
| 37613327625272 | 8 Pullover Toga with Anti-Reflective Face Shield |
| 37613327625265 | 8 Zippered Toga with Peel Away Face Shield |
| 37613327625258 | 8 Pullover Toga with Anti-Reflective Face Shield |
| 37613327625241 | 8 Pullover Toga with Peel Away Face Shield |
| 37613327625234 | 8 Hood with Anti-Reflective Face Shield |
| 37613327625227 | 8 Pullover Toga with Peel Away Face Shield |
| 37613327625210 | 8 Pullover Toga with Peel Away Face Shield |
| 37613327625197 | 8 Pullover Toga with Peel Away Face Shield |
| 37613327625180 | 8 Hood with Peel Away Face Shield |
| 37613327625173 | 8 Hood, Standard |
| 07613327625158 | 8 Charger |
| 07613327627039 | 8 SURGICAL HELMET WITH LIGHT |
| 07613327625202 | 8 BATTERY |
| 07613327625134 | 8 SURGICAL HELMET |
Trademark Results [Steri-Shield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERI-SHIELD 88090848 5715091 Live/Registered |
Steri-Shield Inc. 2018-08-23 |
 STERI-SHIELD 77027919 3356891 Dead/Cancelled |
Portola Packaging, Inc. 2006-10-24 |
 STERI-SHIELD 74568273 1950561 Live/Registered |
Dentex Ltd. Partnership 1994-08-31 |
 STERI-SHIELD 74057722 1777108 Live/Registered |
BIO-MEDICAL DEVICES, INC. 1990-05-10 |
 STERI-SHIELD 73799288 1638981 Dead/Cancelled |
COOK (CANADA) INC. 1989-05-11 |
 STERI-SHIELD 73572963 1402121 Dead/Cancelled |
HENSLEY AND SWANSON PARTNERS 1985-12-10 |
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