H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
STERLING MEDICAL INC
STERLING
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1422598 | 1000220280 | Sterling Medical Products | 1 | N | 2026-01-01 | 401 MARKET ST. Prophetstown IL US 61277 |
| 3008789244 | 3008789244 | STERLING CONTRACT PACKAGING, INC. | 1 | Y | 2026-01-01 | 1875 Moore-Duncan Hwy. Moore SC US 29369 |
| 1831796 | 1831796 | STERLING DIAGNOSTICS, INC. | 1 | N | 2020-04-25 | 36645 Metro Ct Sterling Heights MI US 48312 |
| 3012696636 | 3011630647 | STERLING KNIGHT PHARMACEUTICALS, LLC | 1 | N | 2020-04-25 | 106 E Mulberry St Ripley MS US 38663 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 121380 | 2046417196 | P820069 | |||
| 33382 | 1653149819 | K914039 | SODIUM REAGENT SET | CEI | 1991-10-31 |
| 33382 | 1170072149 | K861713 | SERUM POTASSIUM REAGENT SET | CEJ | 1986-05-23 |
| 33382 | 1762933968 | K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | CIT | 1986-04-03 |
| 33382 | 1177245141 | K860478 | SERUM IRON & IRON BINDING REAGENT SET | JIY | 1986-03-14 |
| 33382 | 1127321532 | K860475 | HEMOGLOBIN REAGENT SET | KHG | 1986-03-03 |
| 33382 | 1918946355 | K860420 | SICKLE CELL REAGENT SET | GHM | 1986-02-24 |
| 33382 | 1612697761 | K860418 | CREATININE REAGENT SET | CGX | 1986-02-11 |
| 33382 | 1642929074 | K860351 | ALKALINE PHOSPHATASE REAGENT SET | CIO | 1986-02-11 |
| 33382 | 1443207793 | K860341 | TOTAL PROTEIN (BIURET) REAGENT SET | CEK | 1986-02-11 |
| 33382 | 1075855307 | K860340 | SERUM ALBUMIN (BCG) REAGENT SET | CIX | 1986-02-19 |
| 33382 | 1051003544 | K860216 | SGOT (AST) REAGENT SET | CIQ | 1986-04-03 |
| 33382 | 1595202879 | K860214 | TOTAL BILIRUBIN REAGENT SET | CIG | 1986-03-17 |
| 33382 | 1595200136 | K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | CDL | 1986-02-06 |
| 33382 | 1883512405 | K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | LFQ | 1986-02-11 |
| 33382 | 1773731235 | K860096 | CPK REAGENT SET (COLORIMETRIC) | CGS | 1986-02-11 |
| 33382 | 1737525490 | K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) | CGA | 1985-11-22 |
| 33382 | 1692136536 | K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | GMP | 1985-08-19 |
| 33382 | 1489936623 | K801422 | SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. | LCP | 1980-07-08 |
| 195514 | 1538952558 | K020540 | REGENECARE WOUND GEL | SEJ | 2002-11-01 |
| 212719 | 1062942588 | ||||
| 212719 | 1134462276 | ||||
| 212719 | 1300385935 | ||||
| 212719 | 1304517591 | ||||
| 121380 | 1335714330 | ||||
| 33382 | 1359774142 | ||||
| 212719 | 1403223540 | ||||
| 33382 | 1493181965 | ||||
| 33382 | 1587087232 | ||||
| 195514 | 1735398580 | ||||
| 212719 | 1807273026 | ||||
| 33382 | 1976426644 | ||||
| 33382 | 2039564452 | ||||
| 212719 | 1033857698 | ||||
| 212719 | 1057524785 | ||||
| 212719 | 1066292275 | ||||
| 212719 | 1114693665 | ||||
| 212719 | 1298117929 | ||||
| 212719 | 1299897739 | ||||
| 121380 | 1339011775 | ||||
| 212719 | 1355746095 | ||||
| 212719 | 1370714198 | ||||
| 212719 | 1370923136 | ||||
| 212719 | 1393799129 | ||||
| 212719 | 1412330060 | ||||
| 212719 | 1416069951 | ||||
| 212719 | 1474477527 | ||||
| 212719 | 1524102380 | ||||
| 212719 | 1532228290 | ||||
| 212719 | 1574152112 | ||||
| 212719 | 1628999287 | ||||
| 212719 | 1668184248 | ||||
| 212719 | 1737696659 | ||||
| 212719 | 1772818745 | ||||
| 212719 | 1799406929 | ||||
| 212719 | 1801765878 | ||||
| 212719 | 1848711641 | ||||
| 212719 | 1890151544 | ||||
| 212719 | 1980025262 | ||||
| 121380 | 2001009759 | ||||
| 212719 | 2067016811 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SEJ | 1 | 2002-11-01 |
| CEI | 1 | 1991-10-31 |
| CEJ | 1 | 1986-05-23 |
| CIT | 1 | 1986-04-03 |
| CIQ | 1 | 1986-04-03 |
| CIG | 1 | 1986-03-17 |
| JIY | 1 | 1986-03-14 |
| KHG | 1 | 1986-03-03 |
| GHM | 1 | 1986-02-24 |
| CIX | 1 | 1986-02-19 |
| CGX | 1 | 1986-02-11 |
| CEK | 1 | 1986-02-11 |
| CIO | 1 | 1986-02-11 |
| LFQ | 1 | 1986-02-11 |
| CGS | 1 | 1986-02-11 |
| CDL | 1 | 1986-02-06 |
| CGA | 1 | 1985-11-22 |
| GMP | 1 | 1985-08-19 |
| LCP | 1 | 1980-07-08 |
PMN#
SIMPLICITY EASY ACCESS P INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY QD EASY P INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
STERLING MEDIVATIONS, INC.
SIMPLICITY EASY SOFT INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY STARPLUS SOFT INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY EASY ACCESS INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
STERLING MEDIVATIONS, INC.
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
STERLING MEDIVATIONS, INC.
SIMPLICITY EURO QD INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
STERLING MEDIVATIONS, INC.
SIMPLICITY SOFT QD SILVER INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY WING INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY WINGED QD INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY SILVER SET SOFT INFUSION
STERLING MEDIVATIONS, INC.
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
STERLING MEDIVATIONS, INC.
INJECTRITE-C15 AND INJECTRITE-C30
STERLING MEDIVATIONS, INC.
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
STERLING MEDIVATIONS, INC.
SIMPLICITY SOFT INFUSION SET
STERLING MEDIVATIONS, INC.
SIMPLICITY DISPOSABLE PEN NEEDLE
STERLING MEDIVATIONS, INC.
IIRAD DIRECTRAY OPERATOR CONSOLE
STERLING DIAGNOSTIC IMAGING, INC.
IISYS PACS SYSTEM
STERLING DIAGNOSTIC IMAGING, INC.
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
STERLING DIAGNOSTIC IMAGING, INC.
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
STERLING DIAGNOSTIC IMAGING, INC.
RAVEN DRY PRINTER
STERLING DIAGNOSTIC IMAGING, INC.
HELIOS LASER IMAGER 1417
STERLING DIAGNOSTIC IMAGING, INC.
LINX NETWORKING SYSTEM
STERLING DIAGNOSTIC IMAGING, INC.
CARESS SANITARY NAPKIN
STERLING U.S.A., INC.
MICROPROTEIN REAGENT SET
STERLING DIAGNOSTICS, INC.
TRIGLYCERIDES REAGENT SET
STERLING DIAGNOSTICS, INC.
SODIUM REAGENT SET
STERLING DIAGNOSTICS, INC.
PHOSPHOLIPID REAGENT SET
STERLING DIAGNOSTICS, INC.
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
STERLING DRUG, INC.
BIOBRANE(R) II
STERLING DRUG, INC.
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
STERLING DRUG, INC.
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
STERLING DIAGNOSTICS, INC.
VANILMANDELIC ACID (VMA) REAGENT SET
STERLING DIAGNOSTICS, INC.
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
STERLING DIAGNOSTICS, INC.
UREA NITROGEN (GLDH) REAGENT SET (UV)
STERLING DIAGNOSTICS, INC.
ALT (SGPT) REAGENT SET (UV RATE)
STERLING DIAGNOSTICS, INC.
Applications#
GUDID#
ALBUMIN RGT SET - 2110-0
2016-09-14
CREATININE/ ENDPOINT - CREATININE/ENDPOINT
2016-09-14
UREA NITROGEN (BERTHELOT) - 2290-0
2016-09-14
UREA NITROGEN (BERTHELOT) - UREA NITROGEN/COLOR (BERTHELOT)
2016-09-14
TOTAL BILIRUBIN - TOTAL BILIRUBIN (MODIFIED MALLOY-EVELYN)
2016-09-14
RPR CARD TEST - S168-0
2016-09-14
TOTAL AND DIRECT BILIRUBIN - TOTAL AND DIRECT BILIRUBIN (MODIFIED MALLOY-EVELYN)
2016-09-14
SUPER SENSITIVE CHOLESTEROL - SUPER SENSITIVE CHOLESTEROL (TRINDER/COD-CEH)
2016-09-14
POTASSIUM - POTASSIUM (TURBIDIMETRIC)
2016-09-14
SODIUM KIT - SODIUM KIT (COLORIMETRIC METHOD)
2016-09-14
T. PROTEIN RGT SET - TOTAL PROTEIN RGT SET
2016-09-14
SICKLE CELL - SICKLE CELL (QUALITATIVE Hb-S TEST)
2016-09-14
ALKALINE PHOSPHATASE - ALKALINE PHOSPHATASE (COLORIMETRIC TMP)
2016-09-14
ENZYMATIC URIC ACID - URIC ACID ENZYMATIC URICASE TRINDER
2016-09-14
TRIGLYCERIDES - GPO - TRIGLYCERIDES -GPO TEST
2016-09-14
SGPT Colorimetric - SGPT/ALT COLORIMETRIC
2016-09-14
SGOT COLORIMETRIC - SGOT/AST COLORIMETRIC
2016-09-14
SERUM IRON/IBC - SERUM IRON/IBC COLORIMETRIC
2016-09-14
GLYCOHEMOGLOBIN - 2193-0
2016-09-14
ENZYMATIC GLUCOSE - GLUCOSE ENZYMATIC TRINDER
2016-09-14
CPK / COLORIMETRIC - CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC
2016-09-14
HDL CHOLESTEROL - HDL CHOLESTEROL (PEG METHOD)
2016-09-14
ENZYMATIC CHOLESTEROL - ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
2016-09-14
ENZYMATIC CHOLESTEROL - ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
2016-09-14