| Primary Device ID | 00860183001597 |
| NIH Device Record Key | a8ab1051-6af7-4542-bbfc-f85e0d03c35a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kit, Container, Fixation Pins, Immobilizer |
| Version Model Number | 300159 |
| Company DUNS | 082344400 |
| Company Name | ZAP SURGICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860183001597 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
[00860183001597]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-25 |
| Device Publish Date | 2025-11-17 |
| 00860014658303 - PinZ Patient Immobilizer | 2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab |
| 00860183001542 - Kit, Container, Head Immobilizer | 2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab |
| 00860183001573 - ZAP-Axon Treatment Planning System | 2025-11-25 The dedicated software application used to create, optimize, and review treatment plans for the ZAP-X Radiosurgery System. It pr |
| 00860183001580 - DoseGuard | 2025-11-25 The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of pati |
| 00860183001597 - Kit, Container, Fixation Pins, Immobilizer | 2025-11-25An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session. |
| 00860183001597 - Kit, Container, Fixation Pins, Immobilizer | 2025-11-25 An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient tab |
| 00860183001504 - Zap-X Radiosurgery System | 2018-10-01 The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radi |
| 00860183001511 - Zap-X Treatment Delivery Software | 2018-10-01 The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com |
| 00860183001528 - Zap-X Treatment Planning Software | 2018-10-01 The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com |