| Primary Device ID | B354SD3883760 |
| NIH Device Record Key | e149e141-64e1-498e-a813-0913e9664e92 |
| Commercial Distribution Discontinuation | 2022-04-19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reusable Non-Locking Comfort Handle |
| Version Model Number | SD388376 |
| Catalog Number | SD388376 |
| 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 | B354SD3883760 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
[B354SD3883760]
Peracetic Acid
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2019-04-29 |
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