Prospera Spectruum Negative Pressure Wound Therapy System
Deroyal Industries, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1034876 | 1034876 | DEROYAL INDUSTRIES, INC. | 1 | N | 2026-01-01 | 185 RICHARDSON WAY MAYNARDVILLE TN US 37807 |
| 1043214 | 1043214 | DEROYAL INDUSTRIES, INC. | 1 | Y | 2026-01-01 | 200 DEBUSK LN. POWELL TN US 37849 |
| 1051550 | 1051550 | DEROYAL INDUSTRIES, INC. | 1 | N | 2026-01-01 | 165 RICHARDSON WAY MAYNARDVILLE TN US 37807 |
| 1054241 | 1000112877 | DeRoyal Industries, Inc. | 1 | N | 2026-01-01 | 1135 HWY. 33 SOUTH NEW TAZEWELL TN US 37825 |
| 1055236 | 1000112968 | DEROYAL INDUSTRIES, INC. | 1 | N | 2026-01-01 | 1211 HWY. 33 SOUTH NEW TAZEWELL TN US 37825 |
| 1057404 | 1000208576 | DeRoyal Industries, Inc. | 1 | N | 2026-01-01 | 300 DEBUSK LN. POWELL TN US 37849 |
| 1060680 | 1000208624 | DeRoyal Industries, Inc. | 1 | Y | 2026-01-01 | 1703 Highway 33 S NEW TAZEWELL TN US 37825 |
| 2320762 | 3003040625 | DEROYAL INDUSTRIES, INC. | 1 | Y | 2026-01-01 | 1595 Highway 33 S NEW TAZEWELL TN US 37825 |
| 3008583452 | 3008583452 | DeRoyal Industries, Inc. | 1 | N | 2026-01-01 | 213 DeBusk Lane Powell TN US 37849 |
| 1048770 | 1048770 | DeRoyal Industries, Inc. | 1 | N | 2020-04-25 | 104 WHEELER ST. PORTLAND TN US 37148 |
| 1123071 | 1000123222 | DeRoyal Industries, Inc. | 1 | N | 2020-04-25 | 164 Giles Hollow Road ROSE HILL VA US 24281 |
| 3005011024 | 3005011024 | DeRoyal Industries, Inc. | 1 | Y | 2020-04-25 | 1501 EAST CENTRAL AVE. La Follette TN US 37766 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00749756401944 | DeRoyal - Lumitech Film Dressings | +1(865)938-7828 | udisupport@deroyal.com |
| 00749756998642 | DeRoyal - SUTURE TICRON BRD BLUE CV-305SZ 2-0 18 IN | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998901 | DeRoyal - SUTURE STAINLESS STEEL MONOV-40 SZ 6 4-18 IN | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998918 | DeRoyal - SUTURE PROLENE BLUE 7-04-18 IN NO NDL | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998925 | DeRoyal - SUTURE MONOCRYL PLUS CT-1SZ 2-0 36 IN | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998956 | DeRoyal - SUTURE PROLENE MONO BLUE C-1 | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998963 | DeRoyal - SUTURE STRATAFIX SPIRAL MONO | +1(888)938-7828 | udisupport@deroyal.com |
| 00749756998970 | DeRoyal - SUTURE PROLENE BLUE BV-1SZ 7-0 18 IN | +1(888)938-7828 | udisupport@deroyal.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 660 | 1544195808 | K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | DXZ | 2000-07-07 |
| 675 | 1544195808 | K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | DXZ | 2000-07-07 |
| 660 | 1366541511 | K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | HIF | 2000-06-20 |
| 672 | 1366541511 | K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | HIF | 2000-06-20 |
| 660 | 1249858011 | K992363 | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN | FRO | 1999-08-12 |
| 672 | 1249858011 | K992363 | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN | FRO | 1999-08-12 |
| 660 | 1294509750 | K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | FRO | 2000-06-07 |
| 675 | 1294509750 | K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | FRO | 2000-06-07 |
| 660 | 1513469783 | K992062 | SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES | LZA | 1999-08-25 |
| 660 | 1906860665 | K991855 | CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX | GEI | 1999-06-15 |
| 29058 | 1906860665 | K991855 | CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX | GEI | 1999-06-15 |
| 660 | 1822329973 | K991525 | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF | DXQ | 1999-07-20 |
| 660 | 2044777237 | K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | NAD | 2000-01-31 |
| 660 | 1097432298 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | 1999-02-10 |
| 672 | 1097432298 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | 1999-02-10 |
| 675 | 1097432298 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | 1999-02-10 |
| 29058 | 1097432298 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | 1999-02-10 |
| 660 | 1358963317 | K982472 | GENICON TROCAR | GEA | 1999-02-04 |
| 672 | 1358963317 | K982472 | GENICON TROCAR | GEA | 1999-02-04 |
| 660 | 1701704098 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | 1998-08-11 |
| 672 | 1701704098 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | 1998-08-11 |
| 675 | 1701704098 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | 1998-08-11 |
| 660 | 1778163531 | K982123 | CONTRAST CONTROL DEVICE | FPA | 1998-07-21 |
| 29058 | 1778163531 | K982123 | CONTRAST CONTROL DEVICE | FPA | 1998-07-21 |
| 29058 | 1896195937 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | 1998-07-09 |
| 660 | 1896195937 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | 1998-07-09 |
| 668 | 1896195937 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | 1998-07-09 |
| 672 | 1896195937 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | 1998-07-09 |
| 675 | 1896195937 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | 1998-07-09 |
| 660 | 1597743975 | K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | 1998-08-20 |
| 29058 | 1597743975 | K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | DRS | 1998-08-20 |
| 29058 | 1986881844 | K981613 | COBE SMARXT TUBING AND CONNECTORS | DWE | 1998-10-26 |
| 660 | 1986881844 | K981613 | COBE SMARXT TUBING AND CONNECTORS | DWE | 1998-10-26 |
| 660 | 1462849644 | K981582 | SURGILON, DERMALON, & OPHTHALON | GAR | 1998-07-13 |
| 675 | 1462849644 | K981582 | SURGILON, DERMALON, & OPHTHALON | GAR | 1998-07-13 |
| 660 | 1700677360 | K981393 | MICROCOOL SURGICAL GOWN | FYA | 1998-07-10 |
| 675 | 1700677360 | K981393 | MICROCOOL SURGICAL GOWN | FYA | 1998-07-10 |
| 660 | 2007605233 | K981386 | MANAN BLUNT NEEDLE | FPA | 1998-06-29 |
| 29058 | 2007605233 | K981386 | MANAN BLUNT NEEDLE | FPA | 1998-06-29 |
| 29058 | 1466197986 | K981128 | SOFSILK SUTURE | GAP | 1998-05-11 |
| 660 | 1466197986 | K981128 | SOFSILK SUTURE | GAP | 1998-05-11 |
| 660 | 1067002746 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 675 | 1067002746 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 29058 | 1067002746 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 660 | 1640467675 | K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | IMD | 1998-02-26 |
| 660 | 1906262738 | K980210 | VARIOUS SURGICAL OR PATIENT DRAPES | KKX | 1998-05-15 |
| 660 | 2000632433 | K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) | GEI | 1998-02-03 |
| 675 | 2000632433 | K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) | GEI | 1998-02-03 |
| 660 | 1302371667 | K973619 | KENDALL CURITY NON-ADHERING DRESSING | KMF | 1997-12-10 |
| 660 | 1672594414 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | 1997-12-15 |
| 672 | 1672594414 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | 1997-12-15 |
| 660 | 1498207692 | K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | 1997-10-08 |
| 672 | 1498207692 | K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | 1997-10-08 |
| 660 | 1402479307 | K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | GIM | 1997-06-17 |
| 675 | 1402479307 | K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | GIM | 1997-06-17 |
| 660 | 1838188570 | K971019 | CHASE VESSEL CANNULA | DWF | 1997-07-21 |
| 29058 | 1838188570 | K971019 | CHASE VESSEL CANNULA | DWF | 1997-07-21 |
| 29058 | 1323391661 | K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | GEI | 1997-05-22 |
| 660 | 1323391661 | K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | GEI | 1997-05-22 |
| 675 | 1323391661 | K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | GEI | 1997-05-22 |
| 660 | 1973966195 | K970946 | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET | LJH | 1997-06-10 |
| 660 | 1732007829 | K970891 | DRAPE, SURGICAL-LATEX | KKX | 1997-08-22 |
| 660 | 1914782042 | K970855 | CLAVE CONNECTOR | FPA | 1997-06-24 |
| 675 | 1914782042 | K970855 | CLAVE CONNECTOR | FPA | 1997-06-24 |
| 660 | 1225943432 | K970513 | GENERAL PURPOSE TRANDUCER COVER | ITX | 1997-06-20 |
| 29058 | 1225943432 | K970513 | GENERAL PURPOSE TRANDUCER COVER | ITX | 1997-06-20 |
| 660 | 1558457860 | K965054 | PENCIL | GEI | 1997-01-24 |
| 675 | 1558457860 | K965054 | PENCIL | GEI | 1997-01-24 |
| 660 | 1254194594 | K964435 | PRIMARY IV SET | FMG | 1997-04-02 |
| 675 | 1254194594 | K964435 | PRIMARY IV SET | FMG | 1997-04-02 |
| 660 | 1981347360 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | 1996-12-18 |
| 660 | 1354198814 | K963253 | SYNTHETIC ABSORBABLE SURGICAL SUTURE | GAM | 1996-10-08 |
| 660 | 1667488514 | K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | GEI | 1996-09-03 |
| 672 | 1667488514 | K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | GEI | 1996-09-03 |
| 675 | 1667488514 | K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | GEI | 1996-09-03 |
| 660 | 1702915474 | K962886 | ANESTHESIA CONDUCTION NEEDLE | BSP | 1996-10-09 |
| 675 | 1702915474 | K962886 | ANESTHESIA CONDUCTION NEEDLE | BSP | 1996-10-09 |
| 29058 | 1702915474 | K962886 | ANESTHESIA CONDUCTION NEEDLE | BSP | 1996-10-09 |
| 660 | 2004851463 | K962042 | GLASS SYRINGE | FMF | 1996-10-08 |
| 675 | 2004851463 | K962042 | GLASS SYRINGE | FMF | 1996-10-08 |
| 660 | 2005526565 | K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | GEI | 1996-10-08 |
| 675 | 2005526565 | K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | GEI | 1996-10-08 |
| 29058 | 2005526565 | K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | GEI | 1996-10-08 |
| 660 | 1643928299 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | 1996-05-15 |
| 675 | 1643928299 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | 1996-05-15 |
| 660 | 1628382568 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | 1996-06-21 |
| 675 | 1628382568 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | 1996-06-21 |
| 660 | 1863126574 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | 1996-04-03 |
| 675 | 1863126574 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | 1996-04-03 |
| 660 | 1466821592 | K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | 1996-09-12 |
| 672 | 1466821592 | K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | 1996-09-12 |
| 660 | 1875700757 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | 1996-05-14 |
| 675 | 1875700757 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | 1996-05-14 |
| 660 | 1652442413 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 29058 | 1652442413 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | 1996-03-28 |
| 660 | 1857383276 | K960492 | SI CONTROLLER MODEL SI 500 | BTA | 1996-12-23 |
| 672 | 1857383276 | K960492 | SI CONTROLLER MODEL SI 500 | BTA | 1996-12-23 |
| 660 | 1578801642 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | 1996-02-01 |
| 675 | 1578801642 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | 1996-02-01 |
| 29058 | 1578801642 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | 1996-02-01 |
| 660 | 1992223946 | K954808 | USSC POLYPROPLENE SUTURE | GAW | 1996-02-27 |
| 660 | 1977547352 | K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | MPO | 1996-01-11 |
| 660 | 1951829246 | K954108 | MODIFIED VERSAPORT | GCJ | 1995-10-17 |
| 660 | 1221545846 | K954088 | TELESCOPING PENEVAC | GEI | 1995-09-22 |
| 660 | 1939197418 | K953952 | DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF | DXQ | 1995-09-28 |
| 660 | 1160205824 | K953418 | ELECTROCAUTERY SHROUD | GCJ | 1995-10-07 |
| 675 | 1160205824 | K953418 | ELECTROCAUTERY SHROUD | GCJ | 1995-10-07 |
| 29058 | 1160205824 | K953418 | ELECTROCAUTERY SHROUD | GCJ | 1995-10-07 |
| 660 | 1652147934 | K953289 | TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET | DXZ | 1995-08-21 |
| 660 | 1659210886 | K952775 | DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING | MGQ | 1995-10-06 |
| 660 | 1614392862 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | 1995-07-14 |
| 660 | 1671994364 | K952030 | LOOP/SQUARE ELECTRODE | HGI | 1996-07-31 |
| 672 | 1671994364 | K952030 | LOOP/SQUARE ELECTRODE | HGI | 1996-07-31 |
| 675 | 1671994364 | K952030 | LOOP/SQUARE ELECTRODE | HGI | 1996-07-31 |
| 29058 | 1671994364 | K952030 | LOOP/SQUARE ELECTRODE | HGI | 1996-07-31 |
| 660 | 1507453812 | K951802 | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT | DXT | 1995-07-21 |
| 660 | 1495880625 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 675 | 1495880625 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 660 | 1039017605 | K951214 | STERILE EQUIPMENT COVER | KKX | 1995-05-16 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 105 | 2016-04-21 |
| KKX | 30 | 2010-11-09 |
| FMF | 29 | 2018-01-31 |
| FPA | 29 | 2014-08-18 |
| DXT | 22 | 2016-03-25 |
| FRO | 20 | 2018-07-02 |
| GCJ | 15 | 2017-08-17 |
| FMI | 15 | 2005-09-13 |
| FYA | 14 | 2021-07-21 |
| DQO | 12 | 2010-07-01 |
| DWF | 11 | 2013-03-27 |
| KOD | 11 | 2004-07-20 |
| FZP | 10 | 2018-10-30 |
| DXC | 10 | 2011-10-14 |
| DXZ | 10 | 2000-11-07 |
| FLL | 9 | 2020-12-23 |
| OMP | 8 | 2025-11-21 |
| HIF | 8 | 2020-07-29 |
| DWJ | 8 | 2010-06-03 |
| BSP | 8 | 2009-10-09 |
| FMG | 7 | 2013-05-23 |
| FOZ | 7 | 2011-07-19 |
| HGI | 7 | 1996-07-31 |
| FRG | 6 | 2012-01-19 |
| EZL | 6 | 2008-10-08 |
| GAM | 6 | 2005-06-29 |
| EFQ | 6 | 1988-04-28 |
| GAW | 5 | 2013-12-06 |
| MTJ | 5 | 2005-03-09 |
| JKA | 5 | 2004-05-14 |
| GAQ | 5 | 1995-01-09 |
| JAA | 5 | 1987-03-06 |
| DYB | 4 | 2024-03-25 |
| KGO | 4 | 2020-04-06 |
| GZJ | 4 | 2008-02-07 |
| DRS | 4 | 2006-09-19 |
| GAP | 4 | 2001-09-19 |
| DWE | 4 | 1998-10-26 |
| OCT | 4 | 1998-08-11 |
| GIM | 4 | 1997-06-17 |
Deroyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DeRoyal Industries, Inc.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
DEROYAL INDUSTRIES, INC.
2026-05-14
2021-05-07
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