HEPRO.US Standard Surgical Gown Case - Material 68gsm A/S Spunlace Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 40 Sterile Pouch
2017-06-21
HEPRO.US
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012098689 | 3012098689 | HEPRO.US | 1 | Y | 2020-04-25 | 325 E 10th Ct Hialeah FL US 33010 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 186496 | 1651028586 | K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle | FMI | 2016-06-07 |
| 186496 | 1993670760 | K151949 | |||
| 186496 | 1426018190 | K150758 | |||
| 186496 | 1396579353 | K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) | LYY | 2015-11-16 |
| 186496 | 1695254296 | K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free) | KGO | 2015-11-16 |
| 186496 | 1900747767 | K141359 | |||
| 186496 | 1705034477 | K133059 | INSULIN PEN NEEDLE | FMI | 2014-02-25 |
| 186496 | 1599748502 | K130230 | STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES | FMF | 2013-11-20 |
| 186496 | 1048514014 | K123987 | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET | JKA | 2013-08-27 |
| 186496 | 1712322933 | K113091 | |||
| 186496 | 1867685301 | K112294 | |||
| 186496 | 1166799689 | K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-02-28 |
| 186496 | 1095139541 | K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | JKA | 2010-07-12 |
| 186496 | 1235632764 | K090336 | SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS | LZA | 2009-07-01 |
| 186496 | 1839849252 | K083686 | BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES | FMF | 2009-07-02 |
| 186496 | 1944428499 | K050999 | YI XIN STERILE SYRINGE FOR SINGLE USE | FMF | 2005-09-02 |
| 186496 | 1038127588 | K002827 | MAC ACUPUNCTURE NEEDLE | MQX | 2001-02-28 |
| 186496 | 1272929567 | ||||
| 186496 | 1440644946 | ||||
| 186496 | 1775184115 | ||||
| 186496 | 1860853677 |
Product Codes Associated With Registrations#
GUDID#
HEPRO.US Reinforced Surgical Gown Case 43gsm - Material 43gsm A/S SMMS Includes 2 hand paper towels 30.5 x 34 cm and 1 Wrapper - 50 Sterile Pouch - Case
2017-06-21
HEPRO.US Standard Surgical Gown L 43gsm 1 Pouch - Standard Surgical Gown L 1 Pouch 43gsm A/S SMMS, with two hand paper towels and wrapper, EO Sterile
2017-06-20
HEPRO.US Reinforced Surgical Gown L 43gsm - Reinforced Surgical Gown L 1 Pouch 43gsm SMMS
2017-06-20
HEPRO.US Standard Surgical Gown 68 gsm - Standard Surgical Gown 68 gsm Single Pouch
2017-06-20
HEPRO.US Reinforced Surgical Gown Single Pouch 68gsm - Reinforced Surgical Gown Single Pouch 68gsm
2017-06-20
HEPRO.US Disposable Nitrile Gloves Class 450 Small - "Hepro.us Disposable Nitrile Gloves Class 450Hepro.us Nitrile Disposable Gloves Deluxe Class 450 Blue 9"" Non Powdered Textured, Size Small 1 Box 100pcs"
2017-06-21
HEPRO.US - Disposable Nitrile Gloves Class 400 Small - "Hepro.us Nitrile Disposable Gloves Deluxe Class 400 Blue 9"" Non Powdered Textured 1Case=10Boxes of 100pcs"
2017-06-21
HEPRO.US Latex Examination Gloves Size Medium - Latex Examination Gloves 10 Boxes of 100 per Case total 1000 Size Medium
2017-06-21
HEPRO.US Case of 10 boxes LARGE Latex Examination Gloves - Hepro.us - Case of 10 boxes of LARGE Latex Examination Gloves.
2017-06-21
HEPRO.US - Latex Examination Gloves SMALL - 100 in one Box - "Latex Examination Gloves, Ambidextrous, Non-Powder 9"". Box of 100pcs. Size Small"
2017-06-21
HEPRO.US – Latex Examination Gloves – 100 per Box - Size Medium - Latex Examination Gloves, Ambidextrous, Non-Powder 9” 100 pcs per Box Size Medium
2017-06-21
HEPRO.US Latex Examination Gloves Size Large - Latex Examination Gloves, Ambidextrous, Non-Powder 9” LargeHEPRO.US – Latex Examination Gloves – Size Large 100 per Box
2017-06-21
"HEPRO.US Sterile Latex Surgical Gloves 7""" - "Sterile Latex Surgical Gloves-Sterilized by Gamma Radiation- 50 Pairs per Box, Size Small 7"""
2017-06-21
"HEPRO.US Sterile Latex Surgical Gloves 7.5""" - "Sterile Latex Surgical Gloves- Sterilized by Gamma Radiation- 50 Pairs per Box, Size Medium 7.5"""
2017-06-21
HEPRO.US Nitrile Standard Class Series 350 - Disposable Nitrile Gloves Series 350, Ambidextrous, Color Blue, Size Small Box 100
2017-06-21
HEPRO.US Nitrile Standard Class Medium Series 350 - Disposable Nitrile Gloves Series 350, Ambidextrous, Color Blue, Size Medium1 box 100 pcs
2017-06-21
HEPRO.US - Nitrile Disposable Gloves Deluxe Class 350 Non-Powdered Textured - Disposable Nitrile Gloves Class 350 - Size LargeHEPRO.US - Nitrile Disposable Gloves Deluxe Class 350 Non-Powdered Texturedbox 100
2017-06-21
HEPRO.US Nitrile Standard Class Series 350 - 1 Box 100pcs - HEPRO.US Nitrile Standard Class Series 350 - 1 Box 100pcsDisposable Nitrile Gloves Series 350, Ambidextrous, Color Blue, Size X-Large
2017-06-21
HEPRO.US Nitrile Standard Class Series 400 - Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Small 1 Box 100pcsHEPRO.US Nitrile Standard Class Series 400
2017-06-21
HEPRO.US Nitrile Standard Class Series 400 Medium - HEPRO.US Nitrile Standard Class Series 400Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Medium 1 Box 100pcs
2017-06-21
HEPRO.US Nitrile Standard Class Series 400 - HEPRO.US Nitrile Standard Class Series 400Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Large 1 Box 100pcs
2017-06-21
HEPRO.US Nitrile Standard Class Series 400 XL - Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size X-Large,1 Box 100pcsHEPRO.US Nitrile Standard Class Series 400
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 450 Medium - Hepro.us Nitrile Disposable Gloves Deluxe Class 450, Color Blue, Non-Powdered, Texture, Size Medium, 1Case of 10 Boxes = 1,000 pcs
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 450 Large - Hepro.us Nitrile Disposable Gloves Deluxe Class 450, Color Blue, Non-Powdered, Textured, Size Large Box 100pcs
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 450 XL - Hepro.us Nitrile Disposable Gloves Deluxe Class 450, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 400 XL - Hepro.us Disposable Nitrile Gloves Class 400Hepro.us Nitrile Disposable Gloves Deluxe Class 400, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 350 - Size Medium - Disposable Nitrile Gloves Class 350 - Size Medium Case total 1000 units 10 boxes 100 units per case
2017-06-21
Hepro.us Disposable Nitrile Gloves Class 350 XL - Hepro.us Disposable Nitrile Gloves Class 350Hepro.us Nitrile Disposable Gloves Deluxe Class 350, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs
2017-06-21
"HEPRO.US Disposable Nitrile Gloves Class 450 powder free 9"" examinati" - "Hepro.us - Disposable Nitrile Gloves Class 450 powder free 9"" examinationHepro.us Nitrile Disposable Gloves Deluxe Class 450 Blue 9"" Non Powdered Textured Size Small 1Case=10Boxes of 100pcs"
2017-06-21
"HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8""" - "HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8""Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until package is opened 8"""
2017-06-21
"HEPRO.US Sterile Latex Surgical Gloves Size X-Large 8.5""" - Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until 50 pairs 1- Box
2017-06-21
HEPRO.US- Exam Class Latex Gloves 100pcs per Box, 10 Boxes per Carton - HEPRO.US- Exam Class Latex Gloves Size Small HEPRO.US- Exam Class Latex Gloves 100pcs per Box, 10 Boxes per Carton
2017-06-21
HEPRO.US- Exam Class Latex Gloves Size X-Large - Case - HEPRO.US- Exam Class Latex Gloves 100pcs per Box, 10 Boxes per Carton
2017-06-21
HEPRO.US Nitrile Examination Glove Size X-Large - 1 Box of 100 pcs - BX - 450 Nitrile XL
2017-06-21
"HEPRO.US Surgical Gloves 7""" - "HEPRO.US Surgical Gloves - Surgical Gloves 1 Case of 10 Boxes - 50 pairs per Box Size 7""Packaging 1 pair per paper bag 50 pairs per box 10 boxes per case Total 500 pairs/Case "
2017-06-21
"HEPRO.US Surgical Latex Gloves 7.5""" - "HEPRO.US- Exam Class Latex Gloves Size Medium 7.5"" Case 500 pairs total"
2017-06-21
"HEPRO.US Surgical Gloves - 50 Pairs Box X-Large 8.5""" - HEPRO.US Surgical Gloves Sterile Latex Surgical Gloves, Non-Powder 1 Right 1 Left = 1 Pair 50pairs per Box- 10 Boxes per Case X-Large
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 350 - "HEPRO.US Nitrile Disposable Gloves Deluxe Class 350 Blue 9"" Non-Powdered Textured - 10 Boxes per Case - Size Small"
2017-06-21
HEPRO.US Disposable Nitrile Gloves Class 350 - Size Large - "Disposable Nitrile Gloves Class 350 - Size LargeHEPRO.US Nitrile Disposable Gloves Deluxe Class 350 Blue 9"" Non-Powdered Textured 1 Box of 100pcs- 10 Boxes per Case"
2017-06-21