| Primary Device ID | 03700483603435 |
| NIH Device Record Key | ed0c3da7-6056-4d34-a0ef-63b10c3caf2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE |
| Version Model Number | OU LC GUIDE RING FOR ARTIFICIAL CHAMBER |
| Catalog Number | 19186 |
| Company DUNS | 275937506 |
| Company Name | MORIA SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700483603428 [Primary] |
| GS1 | 03700483603435 [Package] Contains: 03700483603428 Package: [5 Units] In Commercial Distribution |
| HRH | Trephine, Manual, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-12-29 |
| 03700483603329 | ONE - Punch D9.50mm x1 |
| 03700483600175 | ONE - Punch D9.00mm x1 |
| 03700483600168 | ONE - Punch D8.75mm x1 |
| 03700483600151 | ONE - Punch D8.50mm x1 |
| 03700483600144 | ONE - Punch D8.25mm x1 |
| 03700483600137 | ONE - Punch D8.00mm x1 |
| 03700483603312 | ONE - Punch D7.75mm x1 |
| 03700483603305 | ONE - Punch D7.50mm x1 |
| 03700483603299 | ONE - Punch D7.25mm x1 |
| 03700483603282 | ONE - Punch D7.00mm x1 |
| 03700483603855 | ONE - Punch D6.75mm x1 |
| 03700483603848 | ONE - Punch D6.50mm x1 |
| 03700483603831 | ONE - Punch D6.00mm x1 |
| 03700483625864 | XS PEDIATRIC WIRE SPECULUM |
| 03700483625826 | ROP KIT S SPECULUM/LOOP DEPRESSOR |
| 03700483625789 | ROP KIT XS SPECULUM/LOOP DEPRESSOR |
| 03700483625741 | ROP KIT XS SPECULUM/2IN1 DEPRESSOR |
| 03700483627141 | ROP KIT XS SPECULUM/2IN1 DEPRESSOR |
| 03700483624812 | ONE-DEEP WELL FULL CUT D10.00MM X 1 |
| 03700483624775 | ONE-DEEP WELL FULL CUT D9.50MM X 1 |
| 03700483624737 | ONE-DEEP WELL FULL CUT D9.00MM X 1 |
| 03700483624690 | ONE-DEEP WELL FULL CUT D8.75MM X 1 |
| 03700483624652 | ONE-DEEP WELL FULL CUT D8.50MM X 1 |
| 03700483624614 | ONE-DEEP WELL FULL CUT D8.25MM X 1 |
| 03700483624577 | ONE-DEEP WELL FULL CUT D8.00MM X 1 |
| 03700483624539 | ONE-DEEP WELL FULL CUT D7.75MM X 1 |
| 03700483624492 | ONE-DEEP WELL FULL CUT D7.50MM X 1 |
| 03700483624454 | ONE-DEEP WELL FULL CUT D7.25MM X 1 |
| 03700483624416 | ONE-DEEP WELL FULL CUT D7.00MM X 1 |
| 03700483624379 | ONE-DEEP WELL FULL CUT D6.75MM X 1 |
| 03700483624331 | ONE-DEEP WELL FULL CUT D6.50MM X 1 |
| 03700483624294 | ONE-DEEP WELL FULL CUT D6.00MM X 1 |
| 03700483624256 | ONE-DEEP WELL GUARDED COVER D8.00MM X 1 |
| 03700483624218 | ONE-DEEP WELL GUARDED COVER D7.75MM X 1 |
| 03700483624171 | ONE-DEEP WELL GUARDED COVER D7.50MM X 1 |
| 03700483624133 | ONE-DEEP WELL TRI-FOLD COVER R8.00MM X 1 |
| 03700483624096 | ONE-DEEP WELL TRI-FOLD COVER R7.75MM X 1 |
| 03700483624058 | ONE-DEEP WELL TRI-FOLD COVER R7.50MM X 1 |
| 03700483622573 | ONE-SIEBEL MANIPULATOR X10 |
| 03700483622535 | ONE-LESTER MANIP. STRAIGHT X10 |
| 03700483620265 | One S-flat tying forceps curved x10 |
| 03700483620234 | One S-flat tying forceps angled x10 |
| 03700483620180 | One-pediatric wire speculum x10 |
| 03700483620166 | ROP exam kit W/WS -L x10 |
| 03700483620227 | One S-flat tying forceps angled x5 |
| 03700483603459 | ONE - ROP EXAM. KIT - L |
| 03700483602230 | ONE-BORES MARKER, 12MM |
| 03700483602223 | ONE-BORES MARKER, 12MM |
| 03700483602216 | ONE-MENDEZ RING, 12MM |
| 03700483602193 | ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL |