| Primary Device ID | B3543690 |
| NIH Device Record Key | a22937c1-cf25-4106-89c1-8577393a49b3 |
| Commercial Distribution Discontinuation | 2023-08-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Maryland, Small Head Inner Shaft 10mm |
| Version Model Number | 369 |
| Company DUNS | 047063695 |
| Company Name | ORANGE SURGICAL INSTRUMENTS, LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3543690 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2023-08-07 |
| B354OSLPCDG0 - Lap-port closure device guides 5mm and 10/12 mm | 2024-03-15 Lap-port closure device guides 5mm and 10/12 mm |
| B354OS349440 - Needle Holder Straight 44cm | 2024-03-12 Needle Holder Straight 44cm |
| B354CCBF14100 - Baton 10mm Foam | 2024-02-29 Baton 10mm Foam |
| B354CCBF1450 - Baton 5mm Foam | 2024-02-29 Baton 5mm Foam |
| B354CCLCS50 - Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft | 2024-02-29 Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft |
| B354CCLCS80 - Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft | 2024-02-29 Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft |
| B354CCS50 - Lens Cleaner Foam Sleeve for 5mm Shaft | 2024-02-29 Lens Cleaner Foam Sleeve for 5mm Shaft |
| B354CCS5100 - 5mm x 10mm Foam Sleeves | 2024-02-29 5mm x 10mm Foam Sleeves |