| Primary Device ID | 07290015487139 |
| NIH Device Record Key | a0a81bbe-c93a-459b-a745-81f195f26e41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Introducer D3.5 mm, 167 mm, Trocar. |
| Version Model Number | FAC9200000 |
| Catalog Number | FAC9200000 |
| Company DUNS | 514758619 |
| Company Name | ICECURE MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Lumen/Inner Diameter | 3.5 Millimeter |
| Shaft Length | 167 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Special Storage Condition, Specify | Between 0 and 0 *The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015487139 [Primary] |
| GS1 | 17290015487136 [Package] Package: Shipper Box [1 Units] In Commercial Distribution |
| GDF | Guide, Needle, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
[07290015487139]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-01 |
| Device Publish Date | 2019-10-24 |
| 07290015487061 - Temperature Sensor | 2022-06-15 Temperature Sensor - Use only with IceCure Cryogenic device |
| 07290015487290 - PROSENSE™ SYSTEM 100-127 VAC | 2021-08-19 PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle |
| 07290015487023 - Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric. | 2019-11-01 Cryoprobe - Use only with IceCure Cryogenic device. |
| 07290015487030 - Cryoprobe D3.4 mm/10G, 140 mm, Trocar, Elliptic. | 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device |
| 07290015487047 - Cryoprobe D2.4 mm/13G, 124 mm, Trocar, Spheric. | 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device |
| 07290015487054 - Cryoprobe D2.4 mm/13G, 134 mm, Trocar, Elliptic. | 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device |
| 07290015487078 - Cryoprobe D2.4 mm/13G, 180 mm, Trocar, Elliptic. | 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device |
| 07290015487085 - Cryoprobe D3.4 mm/10G, 185 mm, Trocar, Elliptic. | 2019-11-01 Cryoprobe-Use only with IceCure Cryogenic Device |