Sklar®
Censitrac Ready Simpson Sound W/Grad CM 12.5"
1manufacturer
204catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-18 |
| Record revised | 2022-09-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 85-1414C | In distribution | ||
| 85-2534 | In distribution | ||
| 85-2428 | In distribution | ||
| 85-2513 | In distribution | ||
| 85-2618 | In distribution | ||
| 85-2626 | In distribution | ||
| 85-1351 | In distribution | ||
| 85-2408 | In distribution | ||
| 90-5413C | In distribution | ||
| 85-2514 | In distribution | ||
| 85-2414 | In distribution | ||
| 85-1516 | In distribution | ||
| 90-5415 | In distribution | ||
| 85-2610 | In distribution | ||
| 85-2612 | In distribution | ||
| 85-1016 | In distribution | ||
| 85-1522 | In distribution | ||
| 85-1026 | In distribution | ||
| 85-2519 | In distribution | ||
| 85-2536 | In distribution | ||
| 85-1410 | In distribution | ||
| 85-1018 | In distribution | ||
| 85-1038 | In distribution | ||
| 85-2512 | In distribution | ||
| 85-1016C | In distribution | ||
| 85-1412C | In distribution | ||
| 85-1008 | In distribution | ||
| 85-1512 | In distribution | ||
| 96-2477M | 25 | In distribution | |
| 85-1726 | In distribution | ||
| 85-1338 | In distribution | ||
| 85-1312 | In distribution | ||
| 85-1424 | In distribution | ||
| 85-1038C | In distribution | ||
| 85-1332 | In distribution | ||
| 85-2531 | In distribution | ||
| 85-2412 | In distribution | ||
| 85-1510 | In distribution | ||
| 85-1010 | In distribution | ||
| 85-2615 | In distribution | ||
| 85-2625 | In distribution | ||
| 85-1434C | In distribution | ||
| 85-2535 | In distribution | ||
| 85-1075 | 12 | In distribution | |
| 85-1436C | In distribution | ||
| 85-2616 | In distribution | ||
| 85-1720 | In distribution | ||
| 90-5312 | In distribution | ||
| 85-2537 | In distribution | ||
| 85-1722 | In distribution | ||
| 85-2617 | In distribution | ||
| 85-1520 | In distribution | ||
| 85-1328 | In distribution | ||
| 85-1432C | In distribution | ||
| 85-2527 | In distribution | ||
| 85-2418 | In distribution | ||
| 85-2420 | In distribution | ||
| 85-1350 | In distribution | ||
| 85-1418C | In distribution | ||
| 85-1438 | In distribution | ||
| 85-2517 | In distribution | ||
| 85-1014C | In distribution | ||
| 85-1326 | In distribution | ||
| 85-1424C | In distribution | ||
| 85-2611 | In distribution | ||
| 85-1022C | In distribution | ||
| 85-2630 | In distribution | ||
| 85-2550 | In distribution | ||
| 85-2540 | In distribution | ||
| 85-1418 | In distribution | ||
| 90-5320 | In distribution | ||
| 85-2522 | In distribution | ||
| 85-1022 | In distribution | ||
| 85-1324 | In distribution | ||
| 90-5412 | In distribution | ||
| 85-1030C | In distribution | ||
| 85-1070 | 6 | In distribution | |
| 85-1032C | In distribution | ||
| 85-1430C | In distribution | ||
| 90-5314 | In distribution | ||
| 90-5413 | In distribution | ||
| 85-2530 | In distribution | ||
| 85-1314 | In distribution | ||
| 85-1428C | In distribution | ||
| 85-1352 | In distribution | ||
| 85-1334 | In distribution | ||
| 85-1040 | In distribution | ||
| 85-2521 | In distribution | ||
| 85-1420C | In distribution | ||
| 85-2426 | In distribution | ||
| 85-1034 | In distribution | ||
| 90-5322 | In distribution | ||
| 85-1524 | In distribution | ||
| 85-2619 | In distribution | ||
| 85-2524 | In distribution | ||
| 85-1020 | In distribution | ||
| 85-1028C | In distribution | ||
| 85-1010C | In distribution | ||
| 85-1012 | In distribution | ||
| 85-2432 | In distribution | ||
| 85-1414 | In distribution | ||
| 85-2621 | In distribution | ||
| 85-1024 | In distribution | ||
| 85-1030 | In distribution | ||
| 85-2620 | In distribution | ||
| 85-1428 | In distribution | ||
| 85-1316 | In distribution | ||
| 85-1065 | 17 | In distribution | |
| 85-1432 | In distribution | ||
| 85-1412 | In distribution | ||
| 85-2422 | In distribution | ||
| 85-1318 | In distribution | ||
| 85-1358 | In distribution | ||
| 21-382 | 12 | In distribution | |
| 85-2622 | In distribution | ||
| 85-2523 | In distribution | ||
| 85-1008C | In distribution | ||
| 85-1336 | In distribution | ||
| 85-2525 | In distribution | ||
| 85-2526 | In distribution | ||
| 85-2515 | In distribution | ||
| 85-1345 | 17 | In distribution | |
| 85-1514 | In distribution | ||
| 85-1724 | In distribution | ||
| 85-1528 | In distribution | ||
| 85-2518 | In distribution | ||
| 85-1420 | In distribution | ||
| 85-1322 | In distribution | ||
| 85-1728 | In distribution | ||
| 85-2529 | In distribution | ||
| 85-1732 | In distribution | ||
| 85-1508 | In distribution | ||
| 85-1518 | In distribution | ||
| 85-1308 | In distribution | ||
| 85-2510 | In distribution | ||
| 85-1410C | In distribution | ||
| 85-2539 | In distribution | ||
| 85-1340 | In distribution | ||
| 85-1357 | In distribution | ||
| 85-2424 | In distribution | ||
| 85-1426C | In distribution | ||
| 85-2533 | In distribution | ||
| 85-1020C | In distribution | ||
| 85-1018C | In distribution | ||
| 85-2624 | In distribution | ||
| 85-2629 | In distribution | ||
| 85-1436 | In distribution | ||
| 85-2600 | 20 | In distribution | |
| 85-2538 | In distribution | ||
| 85-2627 | In distribution | ||
| 85-2613 | In distribution | ||
| 85-1714 | In distribution | ||
| 85-1530 | In distribution | ||
| 85-1028 | In distribution | ||
| 85-2608 | In distribution | ||
| 85-1024C | In distribution | ||
| 85-1440 | In distribution | ||
| 85-1730 | In distribution | ||
| 85-2430 | In distribution | ||
| 85-2516 | In distribution | ||
| 85-1355 | In distribution | ||
| 85-1026C | In distribution | ||
| 85-1422C | In distribution | ||
| 85-1410C | In distribution | ||
| 85-1032 | In distribution | ||
| 85-1408 | In distribution | ||
| 85-2614 | In distribution | ||
| 85-1438C | In distribution | ||
| 85-1416 | In distribution | ||
| 85-2410 | In distribution | ||
| 95-382 | In distribution | ||
| 85-1320 | In distribution | ||
| 85-2528 | In distribution | ||
| 85-1430 | In distribution | ||
| 85-1310 | In distribution | ||
| 85-1330 | In distribution | ||
| 85-2511 | In distribution | ||
| 85-1718 | In distribution | ||
| 85-1712 | In distribution | ||
| 85-1012C | In distribution | ||
| 85-2623 | In distribution | ||
| 85-1014 | In distribution | ||
| 85-1356 | In distribution | ||
| 85-1422 | In distribution | ||
| 85-1416C | In distribution | ||
| 85-1342 | 6 | In distribution | |
| 85-1036 | In distribution | ||
| 85-1354 | In distribution | ||
| 85-2436 | In distribution | ||
| 85-1716 | In distribution | ||
| 85-2555 | 20 | In distribution | |
| 85-2532 | In distribution | ||
| 85-2520 | In distribution | ||
| 85-2416 | In distribution | ||
| 85-2508 | In distribution | ||
| 85-1434 | In distribution | ||
| 85-1034C | In distribution | ||
| 98-384 | In distribution | ||
| 98-382 | In distribution | ||
| 85-1353 | In distribution | ||
| 85-2434 | In distribution | ||
| 85-1526 | In distribution | ||
| 85-1426 | In distribution | ||
| 85-2628 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 165 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 105 |
| Hayden Medical | Hayden Medical Inc | 105 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 95 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 87 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 82 |
| V. Mueller | Steris Corporation | 73 |
| BR Surgical, LLC | BR Surgical LLC | 70 |
| Aesculap | Aesculap AG | 63 |
| HNM Medical | HNM Stainless, LLC. | 54 |
| Novo Surgical | Novo Surgical, Inc. | 45 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 21 |
Showing 12 of 33. All products under Sound, Urethral, Metal Or Plastic
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 0 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.