| Primary Device ID | 04711605991667 |
| NIH Device Record Key | c333cf6d-6cf2-45da-bc96-609327781cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The OR Company-InsufflatOR Needle |
| Version Model Number | IN-12-4 |
| Company DUNS | 656305567 |
| Company Name | ADVANCED MEDICAL DESIGN CO., 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 | +88622902627 |
| arnold.yeh@amdintl.com.tw |
| Length | 120 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04711605991643 [Primary] |
| GS1 | 04711605991650 [Package] Contains: 04711605991643 Package: inner box [10 Units] In Commercial Distribution |
| GS1 | 04711605991667 [Package] Contains: 04711605991650 Package: Carton [20 Units] In Commercial Distribution |
| HIF | Insufflator, Laparoscopic |
| 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 | 2016-09-21 |
| 04711605991674 | Insufflation needle 15cm |
| 04711605991667 | Insufflation needle 12cm |