STERRAD 10104
GUDID 10705037048687
STERRAD 100NX, Systems with ALLClear Technology, 2 Doors
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Plasma sterilizer| Primary Device ID | 10705037048687 |
| NIH Device Record Key | 8342b14d-b4fe-4c97-91a1-60f7f002ad77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERRAD |
| Version Model Number | 10104-006 |
| Catalog Number | 10104 |
| Company DUNS | 947451626 |
| Company Name | ADVANCED STERILIZATION PRODUCTS SERVICES INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705037048687 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160903
FDA Product Code
| MLR | Sterilizer, chemical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2017-10-10 |
On-Brand Devices [STERRAD]
| 10705037047550 | Sterrad 100NX Test Pack |
| 10705037016594 | Sterrad NX Validation Kit |
| 10705037016587 | Sterrad NX Validation Kit |
| 10705037016570 | Sterrad Starter Kit (50/100S/NX) |
| 10705037016556 | Sterrad NX Test Pack |
| 10705037016532 | Sterrad 50/100S Sterilizer Cyclesure 24 Validation Kit |
| 10705037016525 | Sterrad 200 Sterilizer CycleSure 24 Validation Kit |
| 10705037016518 | 50/100S Sterilizer Cyclesure 24 Validation Kit |
| 10705037016501 | Sterrad 100NX Validation Kit |
| 10705037016495 | Sterrad 100NX International Validation Kit |
| 10705037016396 | Sterrad 100NX Express Test Pack |
| 10705037016235 | Sterrad CycleSure 24 Test Pack |
| 20705037064479 | Instrument Tray Mats 254 mm X 254 mm (10 in. x 10 in.) |
| 10705037047635 | Instrument Tray Holder Kit |
| 10705037047628 | Sterrad Mat Kit |
| 20705037043177 | Holder Bar for Instrument Tray |
| 20705037043160 | Holder 5 mm x 5 mm x 5 mm |
| 20705037043153 | Holder 15 mm x 15 mm x 15 mm |
| 20705037043146 | Holder 10 mm x 10 mm x 10 mm |
| 20705037043139 | Holder 19 mm x 5 mm x 19 mm |
| 20705037043122 | Holder 5 mm x 19 mm x 5 mm |
| 20705037043115 | Holder 19 mm x 10 mm 19 mm |
| 20705037043108 | Holder 10 mm x 19 x 10 mm |
| 20705037043061 | Instrument Tray Mats 584 mm X 191 mm (23 in. x 7.5 in.) |
| 20705037043054 | Instrument Tray Mats 432 mm X 191 mm (17 in. x 7.5 in.) |
| 20705037043047 | Instrument Tray Mats 279 mm X 191 mm(11 in. x 7.5 in.) |
| 20705037043030 | Instrument Tray Mats 356 mm X 241 mm (14 in. x 9.5 in.) |
| 20705037043023 | Instrument Tray Mats 356 mm X 140 mm (14 in. x 5.5 in.) |
| 20705037043016 | Instrument Tray Mats 229 mm X 140 mm (9 in. x 5.5 in.) |
| 20705037043009 | Instrument Tray Mats165 mm X 64 mm (6.5 in. x 2.5 in.) |
| 20705037049407 | STERRAD VELOCITY BIOLOGICAL INDICATOR |
| 10705037048915 | STERRAD VELOCITY READER |
| 20705037048905 | STERRAD VELOCITY BIOLOGICAL INDICATOR |
| 10705037048700 | STERRAD 100NX, Systems with ALLClear Technology, 2 Doors, DUO |
| 10705037048694 | STERRAD 100NX, Systems with ALLClear Technology, DUO |
| 10705037048687 | STERRAD 100NX, Systems with ALLClear Technology, 2 Doors |
| 10705037048670 | STERRAD 100NX Sterilization System with ALLClear Technology |
| 10705037048656 | STERRAD NX Sterilization System with ALLClear Technology |
| 10705037041657 | Thermometer |
| 10705037016952 | Incubator 120V 58 C |
| 20705037016195 | Chemical Indicator Strip |
| 10705037015191 | Carriage Sterrad 200 4 Wheels |
| 10705037015184 | Shelf Sterrad 200 2-Tier |
| 20705037014900 | Sterrad 100 NX Cassette |
| 20705037014832 | Sterrad NX Cassette |
| 20705037014580 | Sterrad 100s Cassette |
| 10705037047598 | Sterrad 100 NX 2-DR, with DUO |
| 10705037047581 | Sterrad 100 NX 1-DR with DUO |
| 10705037014507 | Sterrad 100 NX 2-DR |
| 10705037014491 | Sterrad 100 NX Sterilizer |
Trademark Results [STERRAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERRAD 73805992 1584504 Live/Registered |
JOHNSON & JOHNSON 1989-06-12 |
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