| Primary Device ID | B354OSRMHB10 |
| NIH Device Record Key | 505f7b59-9790-4acc-b150-3e6c0b9e4ede |
| Commercial Distribution Discontinuation | 2019-11-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Reusable Monpolar Handle |
| Version Model Number | OS-RMH-B |
| Catalog Number | OS-RMH-B |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | B354OS175BC0 [Primary] |
| HIBCC | B354OSRMHB0 [Primary] |
| HIBCC | B354OSRMHB10 [Package] Contains: B354OSRMHB0 Package: [10 Units] Discontinued: 2019-11-14 Not in Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
[B354OSRMHB10]
Peracetic Acid
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2016-11-14 |
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| 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 |