| Primary Device ID | 04546540903877 |
| NIH Device Record Key | fca2e941-9bf5-4a07-bd69-b0de63aeea18 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0400655001 |
| Catalog Number | 0400655001 |
| 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 |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540903877 [Primary] |
| FXZ | HELMET, SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 07613327661989 - KNOTILUS+ | 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327661996 - KNOTILUS+ | 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
| 07613327662009 - KNOTILUS+ | 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327662016 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
| 07613327662023 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
| 07613327662030 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR |
| 07613327662047 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 5.5MM, BIOCOMPOSITE ANCHOR |
| 07613327662054 - ALPHAVENT | 2025-06-24 ALPHAVENT KNOTLESS SP, 6.5MM, BIOCOMPOSITE ANCHOR |