NA
- Primary DI
- 04546540494153
- Brand
- NA
- Company
- STRYKER CORPORATION
- Model
- 0400645000
- Catalog number
- 0400645000
- Device description
- T5 Surgical Helmet with Battery Powered Headlight
- Published
- 2018-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
stryker.comProduct Codes
| Code | Name |
|---|---|
| FXZ | HELMET, SURGICAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FXZ | Helmet, Surgical | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04546540494153 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04546540494153 | 04546540494153 | 4546540494153 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical helmet system | A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)253-3210 | Inst.Stryker.cs@Stryker.com |
Regulatory Flags
- DUNS number
- 196548481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327687637 | N/A | 6517040016 | 6517-040-016 | 2026-03-19 |
| 07613327687644 | N/A | 6517040010 | 6517-040-010 | 2026-03-19 |
| 07613327687651 | N/A | 6517070021 | 6517-070-021 | 2026-03-19 |
| 07613327687668 | N/A | 6517048021 | 6517-048-021 | 2026-03-19 |
| 07613327687675 | N/A | 6517040012 | 6517-040-012 | 2026-03-19 |
| 07613327628357 | RPS | 8808000000 | 8808-000-000 | 2025-10-01 |
| 07613327656763 | BPX | 7900012000 | 7900-012-000 | 2026-03-04 |
| 07613327656770 | BPX | 7900013000 | 7900-013-000 | 2026-03-04 |
| 07613327657760 | BPX | 7900034000 | 7900-034-000 | 2026-03-04 |
| 07613327657777 | BPX | 7900015000 | 7900-015-000 | 2026-03-04 |
| 07613327657784 | BPX | 7900031000 | 7900-031-000 | 2026-03-04 |
| 07613327657791 | BPX | 7900099000 | 7900-099-000 | 2026-03-04 |
| 07613327657807 | N/A | 7900376010 | 7900-376-010 | 2026-03-04 |
| 07613327657814 | BPX | 7900037000 | 7900-037-000 | 2026-03-04 |
| 07613327657821 | N/A | 7900377010 | 7900-377-010 | 2026-03-04 |
| 07613327657838 | N/A | 7900378010 | 7900-378-010 | 2026-03-04 |
| 07613327659429 | BPX | 7900025000 | 7900-025-000 | 2026-03-04 |
| 37613327693288 | Malis | 6760-180-010 | 6760-180-010-Z01 | 2026-02-25 |
| 37613327693295 | Malis | 6760-180-005 | 6760-180-005-Z01 | 2026-02-25 |
| 37613327693363 | Malis | 6760-180-015 | 6760-180-015-Z01 | 2026-02-25 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07613327625134 | Steri-Shield | STRYKER CORPORATION | FXZ | 2025-02-26 |
| 07613327627039 | STERI-SHIELD | STRYKER CORPORATION | FXZ | 2025-02-26 |
| 07613327461312 | N/A | STRYKER CORPORATION | FXZ | 2020-08-06 |
| 07613327461336 | N/A | STRYKER CORPORATION | FXZ | 2020-08-06 |
| 00840277124159 | Innomed, Inc. | INNOMED, INC. | FXZ | 2020-05-18 |
| 04546540152558 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540489579 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540505019 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591579 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591593 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591609 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591623 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591630 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591647 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540591654 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540670069 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540903839 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540903877 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154368167 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154511105 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154511198 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154626366 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154886289 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613154891061 | Flyte | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 07613327115086 | NA | STRYKER CORPORATION | FXZ | 2018-09-24 |
| 04546540152534 | NA | STRYKER CORPORATION | FXZ | 2017-04-05 |