Medline Industries, Inc.
Endoscopy KIT Sierra Endoscopy
2manufacturers in China registered for this device type
337catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | NWU |
| Device type | Endoscope Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2016-11-07 |
| Record revised | 2022-06-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 10, case of 15, case of 12, case of 2, case of 16 |
| Distribution end date | 2022-03-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYKE1761 | In distribution | |
| DYKE1333 | In distribution | |
| DYKE1856 | In distribution | |
| DYKE1829B | In distribution | |
| DYK1196632E | In distribution | |
| DYKE1919 | In distribution | |
| DYKE1447A | In distribution | |
| DYKE1098B | In distribution | |
| DYK1014389E | In distribution | |
| DYNJ55478D | In distribution | |
| DYKE1922 | In distribution | |
| DYKE1846 | In distribution | |
| DYKE1906A | In distribution | |
| DYKE1872 | In distribution | |
| P961596 | In distribution | |
| DYNJ908362B | In distribution | |
| DYKE1364B | In distribution | |
| DYKE1924 | In distribution | |
| DYNDA3058 | In distribution | |
| DYKE1832A | In distribution | |
| DYKE1921 | In distribution | |
| DYKE1793A | In distribution | |
| DYKE1864B | In distribution | |
| DYKE1900 | In distribution | |
| P706881A | In distribution | |
| DYK1177017E | In distribution | |
| DYKE1864 | In distribution | |
| DYKE1884 | In distribution | |
| DYKE1867A | In distribution | |
| DYKE1889 | In distribution | |
| DYKE1554A | In distribution | |
| DYKE1848A | In distribution | |
| DYKE1098A | In distribution | |
| DYNJ81539 | In distribution | |
| DYKE1356 | In distribution | |
| P961580 | In distribution | |
| DYKE1193 | In distribution | |
| DYNJ903826D | In distribution | |
| DYKE1699C | In distribution | |
| DYKE1672B | In distribution | |
| DYKE1088 | In distribution | |
| DYKE1112 | In distribution | |
| DYKE1238 | In distribution | |
| DYKE1194A | In distribution | |
| DYKE1850 | In distribution | |
| DYKE1851 | In distribution | |
| DYKE1009 | In distribution | |
| DYKE1828A | In distribution | |
| DYNJ66034A | In distribution | |
| DYKE1286A | In distribution | |
| DYKE1826B | In distribution | |
| DYKE1868 | In distribution | |
| DYNJ58648J | In distribution | |
| DYKE1742D | In distribution | |
| DYNJ900509O | In distribution | |
| DYKE1725A | In distribution | |
| DYKE1636A | In distribution | |
| DYKE1035A | In distribution | |
| DYKE1164A | In distribution | |
| DYKE1447C | In distribution | |
| DYNJ81490 | In distribution | |
| DYKE1197A | In distribution | |
| DYKE1865 | In distribution | |
| DYKE1873 | In distribution | |
| DYKE1848 | In distribution | |
| DYKE1900A | In distribution | |
| DYKE1928 | In distribution | |
| DYKE1108I | In distribution | |
| DYKE1762 | In distribution | |
| DYKE1871A | In distribution | |
| DYKE1833A | In distribution | |
| DYK1018508E | In distribution | |
| DYKE1142 | In distribution | |
| DYKE1857 | In distribution | |
| DYK1005277E1 | In distribution | |
| DYKE1794A | In distribution | |
| DYNJ54221J | In distribution | |
| DYKENDOBPLUS | In distribution | |
| DYKE1212A | In distribution | |
| DYKE1787A | In distribution | |
| PHS921374 | In distribution | |
| PHS347468000 | In distribution | |
| DYKE1207 | In distribution | |
| DYKE1234 | In distribution | |
| DYKE1114B | In distribution | |
| DYKE1105C | In distribution | |
| DYKE1867 | In distribution | |
| DYKE1447B | In distribution | |
| DYKE1074 | In distribution | |
| DYKE1892 | In distribution | |
| DYKE1326A | In distribution | |
| DYKENDOLWCMP | In distribution | |
| DYKE1822A | In distribution | |
| DYKE1149 | In distribution | |
| DYKE1874 | In distribution | |
| DYKE1134 | In distribution | |
| DYK1178492E1 | In distribution | |
| DYKE1890 | In distribution | |
| DYKE1261A | In distribution | |
| DYKE1871 | In distribution | |
| DYKE1143A | In distribution | |
| DYKE1864A | In distribution | |
| DYKE1863 | In distribution | |
| DYKE1329 | In distribution | |
| DYK1018542E | In distribution | |
| DYKE1941 | In distribution | |
| DYKE1391 | In distribution | |
| DYKE1386 | In distribution | |
| DYNJ55478B | In distribution | |
| DYKENDODBCMP | In distribution | |
| DYNJ903826F | In distribution | |
| DYKE1920 | In distribution | |
| DYKE1355 | In distribution | |
| DYKE1468A | In distribution | |
| DYKE1306 | In distribution | |
| DYKE1509F | In distribution | |
| DYK1206528E | In distribution | |
| DYKE1455C | In distribution | |
| DYKE1858 | In distribution | |
| DYKE1855 | In distribution | |
| DYKE1284 | In distribution | |
| DYKE1437 | In distribution | |
| DYKE1930A | In distribution | |
| DYNJ83704A | In distribution | |
| DYKE1771C | In distribution | |
| DYNJ67382B | In distribution | |
| DYKE1597B | In distribution | |
| DYKE1383B | In distribution | |
| DYKE1847 | In distribution | |
| DYKE1554B | In distribution | |
| DYK1010018E | In distribution | |
| DYNJ56043F | In distribution | |
| DYKE1860 | In distribution | |
| DYKE1828B | In distribution | |
| DYNJ900509N | In distribution | |
| DYKE1876 | In distribution | |
| DYKE1748B | In distribution | |
| DYNJ66447 | In distribution | |
| DYKE1251A | In distribution | |
| DYNJ22661O | In distribution | |
| DYKE1005 | In distribution | |
| DYKE1387 | In distribution | |
| DYKE1882 | In distribution | |
| DYNJ44673G | In distribution | |
| DYKENDOBASFS | In distribution | |
| DYKE1185 | In distribution | |
| DYKE1849 | In distribution | |
| DYKE1124A | In distribution | |
| DYKE1948 | In distribution | |
| DYKE1163C | In distribution | |
| DYK1012268E1 | In distribution | |
| DYKE1061 | In distribution | |
| DYKE1844 | In distribution | |
| DYKENDOUPCMP | In distribution | |
| DYNJ49672L | In distribution | |
| DYKE1902 | In distribution | |
| DYKE1554C | In distribution | |
| P830355A | In distribution | |
| DYKE1793B | In distribution | |
| DYKE1460 | In distribution | |
| DYKE1133A | In distribution | |
| DYNJ60126B | In distribution | |
| DYNJ66596 | In distribution | |
| DYKE1901 | In distribution | |
| DYNJ81514 | In distribution | |
| DYKE1264 | In distribution | |
| DYKE1923 | In distribution | |
| DYKE1068 | In distribution | |
| DYKE1803B | In distribution | |
| DYKE1373 | In distribution | |
| DYKE1481 | In distribution | |
| DYKE1231 | In distribution | |
| DYKE1226 | In distribution | |
| DYKE1223 | Withdrawn | |
| DYKE1239 | Withdrawn | |
| DYKE1057A | Withdrawn | |
| DYK1158839E | Withdrawn | |
| DYKE1346 | Withdrawn | |
| DYKE1442A | Withdrawn | |
| DYKE1368 | Withdrawn | |
| DYKE1364 | Withdrawn | |
| DYKE1266 | Withdrawn | |
| DYKE1097A | Withdrawn | |
| DYKE1122B | Withdrawn | |
| DYKE1135 | Withdrawn | |
| DYKE1184A | Withdrawn | |
| DYKE1232 | Withdrawn | |
| DYKE1229 | Withdrawn | |
| DYKE1189 | Withdrawn | |
| DYK1181432E1 | Withdrawn | |
| DYKE1372 | Withdrawn | |
| DYKE1384 | Withdrawn | |
| DYKE1314A | Withdrawn | |
| DYKE1030B | Withdrawn | |
| DYKE1049 | Withdrawn | |
| DYKE1129 | Withdrawn | |
| DYKE1230 | Withdrawn | |
| DYKE1349 | Withdrawn | |
| DYKE1161A | Withdrawn | |
| DYKE1336A | Withdrawn | |
| DYKE1374 | Withdrawn | |
| DYKE1127 | Withdrawn | |
| DYKE1290 | Withdrawn | |
| DYKE1008A | Withdrawn | |
| DYSAMP200160 | Withdrawn | |
| DYK1008972E | Withdrawn | |
| DYKE1012B | Withdrawn | |
| DYKE1012A | Withdrawn | |
| DYKE1092A | Withdrawn | |
| PHS828060003A | Withdrawn | |
| DYKE1199B | Withdrawn | |
| DYKE1160A | Withdrawn | |
| PHS921368 | Withdrawn | |
| DYK1066527E | Withdrawn | |
| DYK1044978E | Withdrawn | |
| DYKE1390 | Withdrawn | |
| DYK1072097E | Withdrawn | |
| DYKE1382 | Withdrawn | |
| DYKE1271 | Withdrawn | |
| DYKE1325 | Withdrawn | |
| DYSAMP200164 | Withdrawn | |
| DYKE1136A | Withdrawn | |
| DYK1012509E1 | Withdrawn | |
| DYKE1060C | Withdrawn | |
| DYKE1275A | Withdrawn | |
| DYK1217740E | Withdrawn | |
| DYKE1093B | Withdrawn | |
| DYKE1174A | Withdrawn | |
| DYKE1352 | Withdrawn | |
| DYKE1486 | Withdrawn | |
| DYK1017922E | Withdrawn | |
| DYNJ0854969F | Withdrawn | |
| DYKE1305B | Withdrawn | |
| DYKE1394 | Withdrawn | |
| DYKE1179A | Withdrawn | |
| DYKE1202 | Withdrawn | |
| P898396 | Withdrawn | |
| DYKE1350A | Withdrawn | |
| DYKE1288B | Withdrawn | |
| DYKE1353 | Withdrawn | |
| DYK1018533E | Withdrawn | |
| DYKE1126A | Withdrawn | |
| DYKE1110 | Withdrawn | |
| DYKE1159 | Withdrawn | |
| DYKE1392 | Withdrawn | |
| DYKE1375 | Withdrawn | |
| DYK1290102E | Withdrawn | |
| DYKE1397 | Withdrawn | |
| DYKE1105 | Withdrawn | |
| DYKE1242 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10,257 |
| Endo Carry-on Procedure Kit | Medivators Inc | 1,777 |
| Custom Procedure KIT | Medivators Inc | 573 |
| VIA | Us Endoscopy | 519 |
| ACS | American Contract Systems, Inc. | 416 |
| Zutron Medical | Zutron Medical, L.L.C. | 80 |
| Medical Action Industries | Medical Action Industries, Inc. | 54 |
| Essential Kit | Medivators Inc | 44 |
| Preclean Kit | Medivators Inc | 31 |
| VIA procedure kit – custom | Us Endoscopy | 29 |
| Endo Carry-on Custom Procedure Kit | Medivators Inc | 23 |
| Merit Medical® | Merit Medical Systems, Inc. | 17 |
Showing 12 of 23. All products under Endoscope Introducer Kit
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 1824 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 30 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 1072 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 70 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 6257 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-22 | Class II | Under Investigation by firm | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | 2588 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 5969 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 25 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 48 cases (96 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.