| Primary Device ID | B354CCS80 |
| NIH Device Record Key | d734769f-e75a-4e91-b070-a38ec1252e1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lens Cleaner foam Sleeve for 8mm Shaft |
| Version Model Number | CCS8 |
| 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 | 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 | B354CCS80 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
[B354CCS80]
Peracetic Acid
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-29 |
| Device Publish Date | 2024-02-21 |
| B354OS335MGTI0 - Grasper Traumatic Shaft insert 33 cm Disposable | 2025-02-18 |
| B354OS335MGTR0 - Grasper Traumatic with ratchet 33cm Disposable | 2025-02-18 |
| B354OS445RTG0 - Rat Tooth Grasper, 44cm, Disposable | 2025-02-18 |
| B354OS445RTGR0 - Rat Tooth Grasper w/Ratchet, 44cm, Disposable | 2025-02-18 |
| B354OSMCR4MMX5MR0 - 4mm Plug x 5M Monopolar Cable Reusable | 2025-02-18 |
| B354HAF2LGS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Small | 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Small Heart Assist, Single Use, 2 Finger Long, Malleable, 63mm W x 90mm L |
| B354HAF2SHS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Large | 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Large Heart Assist, Sing Use, 2 Finger Short, Malleable 36mm x 54mm |
| B354HAF3LGS0 - Stainless Steel Cardiac 3 Finger Heart Retractor - Small | 2025-01-17 Stainless Steel Cardiac 3 Finger Heart Retractor - Small Heart Assist, Single Use, 3 Finger Long, Malleable, 60mm W x 90mm |