| Primary Device ID | B35430 |
| NIH Device Record Key | 34a986c3-79bb-42f5-962c-1dfb09ee11af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3 Ring suture kit with 5mm and 10 mm swab |
| Version Model Number | B354OS3CDKS |
| Company DUNS | 047063695 |
| Company Name | ORANGE SURGICAL INSTRUMENTS, LLC |
| Device Count | 99999 |
| 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 | B35430 [Unit of Use] |
| HIBCC | B354OS3CDBK1 [Primary] |
| HIBCC | B354OS3CDBK2 [Primary] |
| HIBCC | B354OS3CDBK3 [Primary] |
| HIBCC | B354OS3CDBK4 [Primary] |
| HIBCC | B354OS3CDBK5 [Primary] |
| HIBCC | B354OS3CDBKS1 [Primary] |
| HIBCC | B354OS3CDK1 [Primary] |
| HIBCC | B354OS3CDK2 [Primary] |
| HIBCC | B354OS3CDK3 [Primary] |
| HIBCC | B354OS3CDK4 [Primary] |
| HIBCC | B354OS3CDK5 [Primary] |
| HIBCC | B354OS3CDK9 [Primary] |
| HIBCC | B354OS3CDKS1 [Primary] |
| HIBCC | B354OS3CDKS2 [Primary] |
| HIBCC | B354OS3CDKS3 [Primary] |
| HIBCC | B354OS3CDKS4 [Primary] |
| HIBCC | B354OS3CDKS5 [Primary] |
| HIBCC | B354OS3CDKS9 [Primary] |
| HIBCC | B354OSAPGD2 [Primary] |
| HIBCC | B354OSAPGD3 [Primary] |
| HIBCC | B354OSAPGD4 [Primary] |
| HIBCC | B354OSAPGD5 [Primary] |
| HIBCC | B354OSAPGD9 [Primary] |
| HIBCC | B354OSBC1 [Primary] |
| HIBCC | B354OSBC2 [Primary] |
| HIBCC | B354OSBC3 [Primary] |
| HIBCC | B354OSBC4 [Primary] |
| HIBCC | B354OSBC5 [Primary] |
| HIBCC | B354OSBC9 [Primary] |
| HIBCC | B354OSC60001 [Primary] |
| HIBCC | B354OSC60002 [Primary] |
| HIBCC | B354OSC60003 [Primary] |
| HIBCC | B354OSC60004 [Primary] |
| HIBCC | B354OSC60005 [Primary] |
| HIBCC | B354OSC60009 [Primary] |
| HIBCC | B354OSC6000R1 [Primary] |
| HIBCC | B354OSC6000R2 [Primary] |
| HIBCC | B354OSC6000R3 [Primary] |
| HIBCC | B354OSC6000R4 [Primary] |
| HIBCC | B354OSC6000R5 [Primary] |
| HIBCC | B354OSC6000R9 [Primary] |
| HIBCC | B354OSCFRLG21 [Primary] |
| HIBCC | B354OSCFRLG22 [Primary] |
| HIBCC | B354OSCFRLG23 [Primary] |
| HIBCC | B354OSCFRLG24 [Primary] |
| HIBCC | B354OSCFRLG25 [Primary] |
| HIBCC | B354OSCFRLG29 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B35430]
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[B35430]
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[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
[B35430]
Peracetic Acid
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-17 |
| Device Publish Date | 2023-07-07 |
| 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 |