Sion Biotext Medical L T D

FDA Filings

This page includes the latest FDA filings for Sion Biotext Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8030128
• FEI Number: 3006118668
• Name: Alan
• Owner & Operator: SION BIOTEXT MEDICAL LTD
• Contact Address: 3 Eshel St, Sapirim Industrial Park ; Sderot IL-NOTA 8701002 IL
• US Agent:
  • Alan
  • mdi Consultants, Inc.
  • 516 4829001
  • 516 4820186
  • alan@mdiconsultants.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 55 Northern Blvd. Ste 200; Great Neck, NY 11021 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

• Registration Number: 3015136864
• FEI Number: 3015136864
• Name: Alan Schwartz
• Owner & Operator: SION BIOTEXT MEDICAL LTD
• Contact Address: 3 Eshel St, Sapirim Industrial Park ; Sderot IL-NOTA 8701002 IL
• US Agent:
  • Alan Schwartz
  • mdi Consultants, Inc.
  • 516 4829001
  • 516 4820186
  • alan@mdiconsultants.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 55 Northern Blvd. Suite 200; Great Neck, NY 11021 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2025-06-22
procure TWIN MED, LLC	Otc Medication	2025-06-22
Sion Biotext Bacitracin Zinc Sion Biotext Medical Ltd	Otc Medication	2025-06-14
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2025-06-13
SionBiotext Triple Antibiotic Sion Biotext Medical Ltd	Otc Medication	2025-05-15
SionBiotext Hydrocortisone Sion Biotext Medical Ltd	Otc Medication	2025-05-15
Sion Biotext Bacitracin Zinc Sion Biotext Medical Ltd	Otc Medication	2025-05-15
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2025-05-07
GUDID 17290100666156 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 53J805-3011-000	2025-04-10
GUDID 17290100663308 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 53J805-5001-000	2025-04-03
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2024-12-18
Lemon Sion Biotext Medical Ltd	Otc Medication	2024-05-17
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2024-02-29
Povidone Iodine Gel Swabstick Sion Biotext Medical Ltd	Otc Medication	2024-02-02
Povidone Iodine Sion Biotext Medical Ltd	Otc Medication	2024-01-31
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2024-01-25
Alcohol Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2024-01-25
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2024-01-25
Vitamin A D Sion Biotext Medical Ltd.	Otc Medication	2024-01-25
Povidone Iodine Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2024-01-25
alcohol Sion Biotext Medical Ltd	Otc Medication	2024-01-25
Alcohol Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2024-01-11
alcohol Sion Biotext Medical Ltd	Otc Medication	2024-01-11
alcohol Sion Biotext Medical Ltd	Otc Medication	2024-01-11
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2024-01-09
procure TWIN MED, LLC	Otc Medication	2024-01-09
GUDID 37290101427811 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 54W209-1206-912	2023-09-27
GUDID 37290101427804 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 54W211-1206-912	2023-09-27
GUDID 17290101427817 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 54W209-1205-912	2023-09-27
GUDID 17290101427800 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 54W211-1205-912	2023-09-27
GUDID 07290100663301 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 53J805-5001-000A	2023-09-27
GUDID 07290100663288 SION BIOTEXT MEDICAL LTD	Sion Biotext Medical Ltd. 53J505-1009-000A	2023-09-27
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2022-12-29
procure TWIN MED, LLC	Otc Medication	2022-12-29
Vitamin A D Sion Biotext Medical Ltd.	Otc Medication	2022-12-23
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2022-12-13
Alcohol Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2022-12-13
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2022-12-13
alcohol Sion Biotext Medical Ltd	Otc Medication	2022-12-13
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2022-12-13
Povidone Iodine Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2022-12-13
Vitamins A and D without Lanolin Sion Biotext Medical Ltd	Otc Medication	2022-12-13
Povidone Iodine Sion Biotext Medical Ltd	Otc Medication	2022-12-13
alcohol Sion Biotext Medical Ltd	Otc Medication	2022-12-13
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2022-08-20
procure TWIN MED, LLC	Otc Medication	2022-08-20
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2022-03-10
bacitracin zinc, neomycin sulfate and polymyxin b sulfate Sion Biotext Medical Ltd	Otc Medication	2022-01-29
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2022-01-20
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Lemon Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Alcohol Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2022-01-04
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2022-01-04
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2022-01-04
alcohol Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Bacitracin Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Vitamin A D Sion Biotext Medical Ltd.	Otc Medication	2022-01-04
Hydrocortisone Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Povidone Iodine Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2022-01-04
Hydrocortisone Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Vitamins A and D without Lanolin Sion Biotext Medical Ltd	Otc Medication	2022-01-04
procure TWIN MED, LLC	Otc Medication	2022-01-04
Bacitracin Zinc Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Lanolin Sion Biotext Medical Ltd	Otc Medication	2022-01-04
Povidone Iodine Sion Biotext Medical Ltd	Otc Medication	2022-01-04
alcohol Sion Biotext Medical Ltd	Otc Medication	2022-01-04
procure TWIN MED, LLC	Otc Medication	2021-12-03
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2021-09-30
Lemon Sion Biotext Medical Ltd	Otc Medication	2021-01-12
Povidone Iodine Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2020-11-18
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2020-11-13
Alcohol Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2020-10-15
NDC 68786-300 Sion Biotext Medical Ltd	Alcohol	2020-10-09
Povidone Iodine Sion Biotext Medical Ltd	Otc Medication	2020-03-19
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2020-03-14
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2020-02-06
WHITE PETROLATUM Sion Biotext Medical Ltd	Otc Medication	2019-10-08
Bacitracin Sion Biotext Medical Ltd	Otc Medication	2019-06-19
Bacitracin Zinc Sion Biotext Medical Ltd	Otc Medication	2019-06-19
Lanolin Sion Biotext Medical Ltd	Otc Medication	2019-06-19
alcohol Sion Biotext Medical Ltd	Otc Medication	2019-03-07
Vitamin A D Sion Biotext Medical Ltd.	Otc Medication	2019-02-14
Hydrocortisone Sion Biotext Medical Ltd	Otc Medication	2019-02-14
NDC 68786-223 Sion Biotext Medical Ltd	Hydrocortisone	2019-01-31
KMJ Alan [SION BIOTEXT MEDICAL LTD]	CerviLube	2019-01-31
GDY Alan [SION BIOTEXT MEDICAL LTD]	Surgical operation towel(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Surgical Lap sponge/Abdominal sponge(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Non woven swab/Non woven pad(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Non woven ball(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable)	2018-06-26
GDY Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable)	2018-06-26
FRL Alan [SION BIOTEXT MEDICAL LTD]	Surgical operation towel(without x-ray detectable)	2018-06-26
FRL Alan [SION BIOTEXT MEDICAL LTD]	Non woven swab/Non woven pad(without x-ray detectable)	2018-06-26
FRL Alan [SION BIOTEXT MEDICAL LTD]	Non woven ball(without x-ray detectable)	2018-06-26
KME Alan [SION BIOTEXT MEDICAL LTD]	Baby Blanket	2017-10-31
procure TWIN MED, LLC	Otc Medication	2017-04-06
Hydrocortisone Sion Biotext Medical Ltd	Otc Medication	2017-03-16
NDC 68786-213 Sion Biotext Medical Ltd.	Vitamin A D	2017-02-14
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2016-09-13
Vitamins A and D without Lanolin Sion Biotext Medical Ltd	Otc Medication	2016-02-11
NDC 68786-411 Sion Biotext Medical Ltd	Vitamins A And D Without Lanolin	2016-01-07
Dual Swab Scrub Swabstick Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2015-11-15
Dual Swab Scrub Swabstick Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2015-11-15
NDC 68786-132 Sion Biotext Medical Ltd	Povidone Iodine Prep	2015-07-16
Povidone Iodine Prep Sion Biotext Medical Ltd	Otc Medication	2015-07-16
PMN K142473 SION BIOTEXT MEDICAL LTD	Lubricating Jelly	2015-04-13
NDC 68786-122 Sion Biotext Medical Ltd	Alcohol	2014-04-25
alcohol Sion Biotext Medical Ltd	Otc Medication	2014-04-25
NDC 68786-211 Sion Biotext Medical Ltd	WHITE PETROLATUM	2014-02-16
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2013-12-18
Povidone Iodine Sion Biotext Medical Ltd, Sion Biotext Mexico SAPI de CV	Otc Medication	2013-04-19
Povidone Iodine Sion Biotext Medical Ltd	Otc Medication	2013-04-19
NDC 68786-140 Sion Biotext Medical Ltd	Povidone Iodine	2013-04-17
NDC 68786-130 Sion Biotext Medical Ltd	Povidone Iodine	2013-04-17
Lemon Sion Biotext Medical Ltd	Otc Medication	2013-04-15
NDC 68786-160 Sion Biotext Medical Ltd	Lemon	2013-04-11
ProcureTriple Antibiotic TWIN MED, LLC	Otc Medication	2013-02-21
bacitracin zinc, neomycin sulfate and polymyxin b sulfate Sion Biotext Medical Ltd	Otc Medication	2012-07-11
NDC 68786-232 Sion Biotext Medical Ltd	Lanolin	2012-07-09
NDC 68786-218 Sion Biotext Medical Ltd	Bacitracin	2012-07-09
NDC 68786-216 Sion Biotext Medical Ltd	Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate	2012-07-09
NDC 68786-224 Sion Biotext Medical Ltd	Hydrocortisone	2012-07-06
NDC 68786-220 Sion Biotext Medical Ltd	Bacitracin Zinc	2012-07-06
NDC 68786-120 Sion Biotext Medical Ltd	Alcohol	2011-12-19
NAB Alan [SION BIOTEXT MEDICAL LTD]	Surgical Lap sponge/Abdominal sponge(without x-ray detectable)	2011-10-26
NAB Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(without x-ray detectable)	2011-10-26
NAB Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Surgical Gauze ball/Peanuts ball(without x-ray detectable)	2011-10-26
NAB Alan [SION BIOTEXT MEDICAL LTD]	Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(without x-ray detectable)	2011-10-26
Alcohol Swabstick Dynarex Corporation, Nantong Strip Medical Supply Co., Ltd, Sion Biotext Medical Ltd, Taizhou Kanglin Health Porduces Co. Ltd, Shanghai Yinjing Medical SuppliesCo., Ltd.	Otc Medication	2011-03-24
KOY Alan [SION BIOTEXT MEDICAL LTD]	Adhesive Tape Remover Pad	2010-10-27
povidine iodine Dynarex Corporation, Sion Biotext Medical Ltd	Otc Medication	2010-05-11
PMN K092488 | KMJ Alan [SION BIOTEXT MEDICAL LTD]	Sterile Lubricating Jelly	2010-03-25
NDC 68786-226 Sion Biotext Medical Ltd	Zinc Oxide	2010-02-01
zinc oxide Sion Biotext Medical Ltd, Dynarex Corporation	Otc Medication	2010-02-01
PMN K012816 | FRO Alan [SION BIOTEXT MEDICAL LTD]	Iodoform Packing Strips, Sterile/No	2009-01-12

Similar & Related FDA Registered Companies

• TWIN MED, LLC
• Sion Biotext Mexico SAPI de CV
• Dynarex Corporation
• Nantong Strip Medical Supply Co., Ltd
• Taizhou Kanglin Health Porduces Co. Ltd
• Shanghai Yinjing Medical SuppliesCo., Ltd.

Related Finance Registrations

NCAGE Code	4242A	SION BIOTEXT MEDICAL LTD
CAGE Code	4242A	SION BIOTEXT MEDICAL LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092248972	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	BEAUTY SKIN CARE PREPARATION NESOI 993 CARTONS OF MEDICAL DEVICE PRODUCTS INVOICES 20200229 + 20200230 HS CODE 33.04.9930 + 30.06.7000 TERMS DAP	993 CTN
2020092130839	Haifa,Israel -> Savannah, Georgia	NON WOVEN SPONGES	1792 CAS
2020082639479	Haifa,Israel -> Charleston, South Carolina	1792 CASES OF NON WOVEN SP ONGES	1792 CAS
2020082255415	Algeciras,Spain -> New York/Newark Area, Newark, New Jersey	OF MEDICAL DRESSING PRODUCTS	802 CTN
2020081848564	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SACHET	1222 CAS
2020080332415	Haifa,Israel -> Savannah, Georgia	NON WOVEN SPONGES	1765 CAS
2020072016572	Haifa,Israel -> Savannah, Georgia	NON WOVEN SPONGES	1860 CAS
2020070863299	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	SLAC MEDICAL DEVICES HS 330499	2 PCK