hu-friedy.comCROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
CROSSTEX INTERNATIONAL, INC.
CROSSTEX INTERNATIONAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003675658 | 3003675658 | CROSSTEX INTERNATIONAL, INC. | 1 | N | 2026-01-01 | 621 Hurricane Shoals Rd NW Ste G LAWRENCEVILLE GA US 30046 |
| 3006008984 | 3006008984 | CROSSTEX INTERNATIONAL, INC. | 1 | N | 2026-01-01 | 534 VINE STREET SHARON PA US 16146 |
| 2032573 | 3003706417 | CROSSTEX INTERNATIONAL, INC. | 1 | N | 2020-04-25 | 14059 STAGE RD. Santa Fe Spgs CA US 90670 |
| 2433773 | 2433773 | CROSSTEX INTERNATIONAL, INC. | 1 | Y | 2020-04-25 | 10 RANICK RD. HAUPPAUGE NY US 11788 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10732224002993 | Bite Wing-Ease™ Barrier Sleeves - Bitewing Ease Small | +1(585)359-0167 | regulatoryaffairs@hu-friedy.com |
| 10732224003044 | Slip-Ease™ Cushions - Slipease Large | +1(585)359-0167 | regulatoryaffairs@hu-friedy.com |
| 10732224003068 | Wrap-Ease™ Cushions - Wrap Ease Large | +1(585)359-0167 | regulatoryaffairs@hu-friedy.com |
| 10732224003549 | Advantage Plus Cotton Tipped Applicators - Advantage Plus 3 | +1(800)483-7433 | care@hu-friedy.com |
| 10732224003556 | Advantage Plus Cotton Tipped Applicators - Advantage Plus 6 | +1(800)483-7433 | care@hu-friedy.com |
| 10732224120499 | Surgical Tie-On Mask - Surgical Tie On | +1(585)359-0167 | regulatoryaffairs@hu-friedy.com |
| 50732224001291 | Polyback™ Towels - Polyback Footprint | +1(800)483-7433 | care@hu-friedy.com |
| 50732224001321 | Polyback™ Towels - Polyback Teddy Bear | +1(800)483-7433 | care@hu-friedy.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 7243 | 1608476020 | K993793 | GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE | LYY | 2000-01-12 |
| 7243 | 1718089208 | K992893 | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE | EIA | 1999-09-08 |
| 7243 | 1326979398 | K992868 | DENTAPURE DP40 CARTRIDGE | EIA | 1999-09-07 |
| 7243 | 1553208622 | K990228 | GUTHRIE PRIME POWDER-FREE | LYY | 1999-02-19 |
| 7243 | 1649785661 | K990013 | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES | LZA | 1999-03-23 |
| 7243 | 1811018528 | K984187 | CROSSTEX NON-WOVEN SPONGES | EFQ | 1999-02-18 |
| 7243 | 1426618240 | K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | EFA | 1997-10-09 |
| 7243 | 1264612590 | K955426 | STERITEC CROSS-CHECKS | JOJ | 1996-03-12 |
| 7243 | 1547632853 | K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | KCT | 1994-12-22 |
| 7246 | 1547632853 | K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | KCT | 1994-12-22 |
| 7243 | 1401971834 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | 1993-12-16 |
| 7243 | 1462244966 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | 1989-11-03 |
| 7243 | 1398272698 | K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | JOJ | 1989-08-07 |
| 7243 | 1993114770 | K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | EFN | 1986-07-10 |
| 7243 | 1008455723 | K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | EFN | 1986-08-06 |
| 7243 | 1002295945 | K852170 | EZX YELLOW, BLUE OR ORANGE | EGZ | 1985-09-05 |
| 7243 | 1775480904 | K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | FRG | 2014-02-26 |
| 7243 | 1857296110 | K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS | FXX | 2011-10-06 |
| 7243 | 1611906184 | K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE | FXX | 2010-12-23 |
| 7243 | 1722423397 | K092824 | N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 | MSH | 2009-10-21 |
| 7243 | 1161756572 | K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | FXX | 2008-10-16 |
| 7243 | 1235510053 | K080814 | VOCO PROFLUORID VARNISH | LBH | 2008-07-24 |
| 7243 | 1983670795 | K040098 | VARNISHAMERICA | LBH | 2004-02-04 |
| 7243 | 2005062606 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | 2003-04-14 |
| 7243 | 1033872374 | K012602 | CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX | FXX | 2002-01-22 |
| 7243 | 1849754900 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | 2001-02-09 |
| 7243 | 1351673750 | K002719 | FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A | LYY | 2001-01-26 |
| 7243 | 1025709199 | ||||
| 7243 | 1026519823 | ||||
| 7244 | 1026519823 | ||||
| 7243 | 1037633289 | ||||
| 7243 | 1043636726 | ||||
| 7243 | 1062297617 | ||||
| 7243 | 1157602506 | ||||
| 7244 | 1157602506 | ||||
| 7245 | 1157602506 | ||||
| 7243 | 1158936891 | ||||
| 7243 | 1186455529 | ||||
| 7243 | 1187172945 | ||||
| 7243 | 1277883759 | ||||
| 7243 | 1284772872 | ||||
| 7243 | 1388265113 | ||||
| 7243 | 1434302617 | ||||
| 7243 | 1484236499 | ||||
| 7243 | 1496258622 | ||||
| 7243 | 1549808486 | ||||
| 7243 | 1670175646 | ||||
| 7243 | 1694716429 | ||||
| 7243 | 1760298408 | ||||
| 7243 | 1777250503 | ||||
| 7243 | 1801919735 | ||||
| 7243 | 1840633358 | ||||
| 7243 | 1862035984 | ||||
| 7243 | 1912631721 | ||||
| 7243 | 2047650415 | ||||
| 7245 | 1026519823 | ||||
| 7246 | 1231222751 | ||||
| 7246 | 1549808486 | ||||
| 7246 | 1912631721 | ||||
| 7246 | 1942358220 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FXX | 5 | 2011-10-06 |
| LYY | 3 | 2001-01-26 |
| FRG | 2 | 2014-02-26 |
| LBH | 2 | 2008-07-24 |
| LZA | 2 | 2001-02-09 |
| EIA | 2 | 1999-09-08 |
| JOJ | 2 | 1996-03-12 |
| KCT | 2 | 1994-12-22 |
| EFN | 2 | 1986-08-06 |
| MSH | 1 | 2009-10-21 |
| EGS | 1 | 2003-04-14 |
| EFQ | 1 | 1999-02-18 |
| EFA | 1 | 1997-10-09 |
| EGZ | 1 | 1985-09-05 |
PMN#
GUDID#
Bite Wing-Ease™ Barrier Sleeves - Bitewing Ease Small
2022-09-29
Slip-Ease™ Cushions - Slipease Large
2022-09-29
Wrap-Ease™ Cushions - Wrap Ease Large
2022-09-29
Advantage Plus Cotton Tipped Applicators - Advantage Plus 3
2022-08-19
Advantage Plus Cotton Tipped Applicators - Advantage Plus 6
2022-08-19
Surgical Tie-On Mask - Surgical Tie On
2022-05-06
Polyback™ Towels - Polyback Footprint
2022-10-31
Polyback™ Towels - Polyback Teddy Bear
2022-10-31
Econoback™ Towels - Econoback Footprint
2022-10-31
Econoback™ Towels - Econoback Teddy Bear
2022-10-31
Non-Woven Headrest covers - 10x13 N/W HRC Blue
2022-09-29
Professional Regular Towels - Professional Footprint
2023-07-17
Self-Sealing Sterilization Bag - Self-Sealing Sterilization Bag, 2.5 in x 1.5 in x 8.75 in (6.5 cm x 4 cm x 22 cm)
2022-05-03
Premium Non-Woven Sponges - "2"" x 2"", 4-Ply"
2025-10-23
Ultra Gauze Non-Woven Sponges - "Non-Woven, 4 Ply, Non-Sterile, 2"" x 2"""
2025-10-23
Ultra Gauze Non-Woven Sponges - "Non-Woven, 4 Ply, Non-Sterile, 2"" x 2"""
2022-08-25
Premium Non-Woven Sponges - "2"" x 2"", 4-Ply"
2023-07-17
Sani Vac Evacuation System Cleaner - 2oz bottle
2022-08-19
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 5.25 in x 10 in (13 cm x 25 cm)
2025-07-24
Crosstex International - (POUCH 5.25X10 SELFSEAL)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 4.25 in x 11 in (11 cm x 28 cm)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 7.5 in x 13 in (19 cm x 33 cm)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 10 in x 15 in (25 cm x 38 cm)
2016-11-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 10 in x 15 in (25 cm x 38 cm)
2016-11-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 10 in x 17 in (27 cm x 43 cm)
2017-02-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 12 in x 15 in (30 cm x 38 cm)
2016-11-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 12 in x 15 in (30 cm x 38 cm)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 12 in x 18 in (30 cm x 46 cm)
2016-11-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 12 in x 18 in (30 cm x 46 cm)
2016-11-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 7.5 in x 13 in (19 cm x 33 cm)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 3.5 in x 22 in (9 cm x 56 cm)
2017-02-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 3.5 in x 22 in (9 cm x 56 cm)
2017-02-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 5.25 in x 15 in (13 cm x 38 cm)
2017-02-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 8 in x 16 in (20 cm x 41 cm)
2017-02-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 8 in x 16 in (20 cm x 41 cm)
2017-02-11
Sure-Check Self Sealing Sterilization Pouches - With internal/external multi-variable (parameter) steam indicator. Compatible with steam and EO processes. 5.25 in x 10 in (13 cm x 25 cm)
2016-11-11
Advantage Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 5.25 in x 10 in (13 cm x 25 cm)
2016-11-11
Pink with a Purpose Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 5.25 in x 10 in (13 cm x 25 cm)
2017-02-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 3.25 in x 9 in (8 cm x 23 cm)
2016-11-11
Duo-Check Self-Sealing Sterilization Pouches - Compatible with steam and EO sterilization. With internal/external process indicators. 3.5 in x 9 in (9 cm x 23 cm)
2016-11-11