| Primary Device ID | 00854924006408 |
| NIH Device Record Key | d8638dfc-11f6-4475-b831-af09861fbe2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C2 CryoBalloon EndoGrip |
| Version Model Number | FG-1040 |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854924006408 [Primary] |
| OCX | Endoscopic Irrigation/Suction System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-06 |
| Device Publish Date | 2020-07-29 |
| 04961333255016 - LARYNGOSTROBOSCOPE | 2025-05-05 LARYNGEAL STROBE 9500 |
| 04961333255702 - LARYNGOSTROBOSCOPE | 2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500" |
| 04961333255719 - LARYNGOSTROBOSCOPE | 2025-05-05 9500MC, Lapel Microphone "Accessory for 9500" |
| 04961333255726 - LARYNGOSTROBOSCOPE | 2025-05-05 9500FS, Footswitch "Accessory for 9500 " |
| 00854924006255 - C2 CryoBalloon Ablation System | 2025-04-14 Gen 2 360 Degree Pear Catheter |
| 00854924006293 - C2 CryoBalloon Ablation System | 2025-04-14 Gen 2 360 Degree Standard Catheter |
| 04961333255313 - C2 CryoBalloon | 2024-09-20 |
| 04961333255320 - C2 CryoBalloon | 2024-09-20 |