sn-medical.comSionBiotext Hydrocortisone
Hydrocortisone Acetate 1%
SION BIOTEXT MEDICAL LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8030128 | 3006118668 | SION BIOTEXT MEDICAL LTD | 1 | N | 2026-01-01 | 3 Eshel St, Sapirim Industrial Park Sderot Southern IL 8701002 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290100665619 | Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Glycerine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema. | +97286898650 | customer-service@sn-medical.com |
| 07290100665626 | Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Glycerine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema | +97286898650 | customer-service@sn-medical.com |
| 07290100665633 | Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Calamine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema. | +97286898650 | customer-service@sn-medical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 10442 | 1345921252 | K882567 | SKINCOTE | FRO | 1988-10-05 |
| 10442 | 1262843115 | K150676 | L-Mesitran Dressing Family II- Soft and Tulle | FRO | 2015-12-23 |
| 10442 | 1306281936 | K142473 | Lubricating Jelly | KMJ | 2015-04-13 |
| 10442 | 1295578970 | K120812 | RENAISSANCE | HAW | 2012-07-12 |
| 10442 | 1890506046 | K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | FRO | 2002-10-17 |
| 10442 | 1001460134 | ||||
| 10442 | 1241647409 | ||||
| 10442 | 1459000059 | ||||
| 10442 | 1545766473 | ||||
| 10442 | 1756973015 | ||||
| 10442 | 1914113947 | ||||
| 10442 | 1942287323 | ||||
| 10442 | 2025858778 | ||||
| 10442 | 1052636334 | ||||
| 10442 | 1207840587 | ||||
| 10442 | 1291774782 | ||||
| 10442 | 1345921252 | ||||
| 10442 | 1537842325 | ||||
| 10442 | 1562759416 | ||||
| 10442 | 1622888733 | ||||
| 10442 | 1640541136 | ||||
| 10442 | 1895370641 |
Product Codes Associated With Registrations#
NDC#
Povidone Iodine Prep
Povidone Iodine
alcohol
alcohol
alcohol
alcohol
Povidone Iodine
POVIDONE-IODINE
Povidone Iodine Prep
Povidone Iodine
Povidone Iodine
POVIDONE-IODINE
Lemon
Glycerin
WHITE PETROLATUM
PETROLATUM
Alcohol
Alcohol
SionBiotext Triple Antibiotic
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Povidone Iodine Gel Swabstick
Povidone Iodine Gel Swabstick
Sion Biotext Bacitracin Zinc
Bacitracin Zinc
PMN#
Lubricating Jelly
SION BIOTEXT MEDICAL LTD
GUDID#
Sion Biotext Medical Ltd. - The Amorphous Hydrogel product family is intended to maintain a moist environment by donatingmoisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place inthe wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days.Not made with natural rubber latex Non-cytotoxic Non-irritating
2025-08-25
Sion Biotext Medical Ltd. - The Amorphous Hydrogel product family is intended to maintain a moist environment by donatingmoisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place inthe wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days.Not made with natural rubber latex Non-cytotoxic Non-irritating
2025-08-25
Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Glycerine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema.
2025-07-08
Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Glycerine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema
2025-07-08
Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Calamine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema.
2025-07-08
Sion Biotext Medical Ltd. - Gauze impregnated with a paste containing Zinc Oxide and Calamine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema
2025-07-08
Sion Biotext Medical Ltd. - The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water. The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe. The lubricant is sterilized using gamma radiation.
2025-04-02
Sion Biotext Medical Ltd. - The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water.The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away.Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc.The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe.The lubricant is sterilized using gamma radiation.
2023-09-19
Sion Biotext Medical Ltd. - The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water.The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away.Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc.The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe.The lubricant is sterilized using gamma radiation.
2023-09-19
Sion Biotext Medical Ltd. - The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water. The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe. The lubricant is sterilized using gamma radiation.
2023-09-19
Sion Biotext Medical Ltd. - Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. It leaves a thin breathable film on the skin, which protects it against potential damage. It dries within seconds and does not build up residue on the skin, leaving you ready to apply a new barrier. The product's discreet packaging makes it practical for traveling or useon-the-go.
2023-09-19
Sion Biotext Medical Ltd. - Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.
2023-09-19
Sion Biotext Medical Ltd. - Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. It leaves a thin breathable film on the skin, which protects it against potential damage. It dries within seconds and does not build up residue on the skin, leaving you ready to apply a new barrier. The product's discreet packaging makes it practical for traveling or useon-the-go.
2023-09-19
Sion Biotext Medical Ltd. - Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.
2023-09-19