| Primary Device ID | 07290016745047 |
| NIH Device Record Key | 8bf58c1c-4042-454e-9bd3-9cedcd7d690e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chameleon |
| Version Model Number | 8x40 |
| Catalog Number | CH08-40-75US |
| Company DUNS | 600459882 |
| Company Name | AV MEDICAL TECHNOLOGIES LTD |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 612-200-0118 |
| info@a-vmedical.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016745047 [Primary] |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 07290016745085 | Chameleon PTA Balloon Dilatation Catheter 12x40 mm |
| 07290016745061 | Chameleon PTA Balloon Dilatation Catheter 10x40 mm |
| 07290016745054 | Chameleon PTA Balloon Dilatation Catheter 9x40 mm |
| 07290016745047 | Chameleon PTA Balloon Dilatation Catheter 8x40 mm |
| 07290016745030 | Chameleon PTA Balloon Dilatation Catheter 7x40 mm |
| 07290016745023 | Chameleon PTA Balloon Dilatation Catheter 6x40 mm |
| 07290016745016 | Chameleon PTA Balloon Dilatation Catheter 5x40 mm |