Sheathes Ultrasound Probe Covers
Sheathing Technologies, Inc.
SHEATHING TECHNOLOGIES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2950776 | 1000135740 | SHEATHING TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 675 JARVIS DR. MORGAN HILL CA US 95037 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 46422 | 1259738449 | K990175 | SHEATHES (NON-LATEX), STERILE | ITX | 1999-04-21 |
| 46422 | 1593538199 | K963831 | SHEATHES (NON-LATEX) | ITX | 1997-02-10 |
| 46422 | 1506770207 | K925869 | SHEATHES, STERILE SHEATHES | ITX | 1994-01-06 |
| 46422 | 1933640498 | K153212 | Sheathes Ultrasound Probe Covers | ITX | 2016-03-04 |
| 46422 | 1751398137 | K130041 | SHEATHES STERILE ULTRASOUND GEL | MUI | 2013-02-06 |
| 46422 | 1012199296 | K112827 | SHEATHES ULTRASOND GEL | MUI | 2012-06-22 |
| 46422 | 1162143066 | K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | FDF | 2010-08-03 |
| 46422 | 1906467276 | K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | ITX | 2009-09-28 |
| 46422 | 1007322528 | K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | ITX | 2005-02-28 |
| 46422 | 1896334560 | ||||
| 46422 | 2027170354 |
Product Codes Associated With Registrations#
PMN#
SHEATHES STERILE ULTRASOUND GEL
SHEATHING TECHNOLOGIES, INC.
SHEATHES ULTRASOND GEL
SHEATHING TECHNOLOGIES, INC.
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
SHEATHING TECHNOLOGIES, INC.
SHEATHESISO ULTRASOUND TRANSDUCER COVER
SHEATHING TECHNOLOGIES, INC.
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
SHEATHING TECHNOLOGIES, INC.
SHEATHES (NON-LATEX), STERILE
SHEATHING TECHNOLOGIES, INC.
GUDID#
Sheathes - "Polyurethane, 4""W x 24""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5""W x 24""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 6""W x 24""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 1""D Tapered to 4""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Rolled"
2016-09-23
Sheathes - "Polyurethane, 7/8""D Tapered to 4""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Rolled"
2016-09-23
Sheathes - "Polyurethane, 7/8""D Tapered to 4""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Rolled"
2016-09-23
Sheathes - "Polyurethane, 7/8""D Tapered to 4""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Folded"
2016-09-23
Sheathes - "Polyurethane, 1""D x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Rolled"
2016-09-23
Sheathes - "Polyurethane, 3""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 3.5""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 4""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5.5""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 6""W x 30""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 3""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 3.5""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 4""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 6""W x 36""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 4""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-22
Sheathes - "Polyurethane, 5""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 6""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 4""W x 58""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5""W x 58""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 3""W x 72""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes3D - "Seamless Viral Barrier End, Polyurethane, 1.18""D Tapered to 4""W x 24""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Rolled"
2016-09-22
Sheathes - "Polyurethane, 1""D x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Folded"
2016-09-23
Sheathes - "Polyurethane, 3""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Folded"
2016-09-23
Sheathes - "Polyurethane, 4""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Folded"
2016-09-23
Sheathes - "Polyurethane, 5""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 5.5""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes - "Polyurethane, 6""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-23
Sheathes3D - "Seamless Viral Barrier Contour Curved End, Polyurethane, 1""x 3"" Face to 6""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-22
Sheathes3D - "Seamless Viral Barrier Box End, Polyurethane, 1"" x 3.2"" Face to 6""W x 24""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-22
Sheathes3D - "Seamless Viral Barrier Box End, Polyurethane, 1"" x 3.2"" Face to 6""W x 58""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2016-09-22
Sheathes3D - "Seamless Viral Barrier Box End, Polyurethane, 1"" x 2.9"" Face to 4.5""W x 48""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled"
2017-05-09
Sheathes3D - "Seamless Viral Barrier Adhesive Box End, Polyurethane, 1"" x 2.9"" Face to 6""W x 24""L, Sterile, Extended Field Ultrasound Probe Cover with 2 Elastics, Rolled"
2018-02-28
Sheathes3D - "Seamless Viral Barrier Adhesive Box End, Polyurethane, 1"" x 2.9"" Face to 4.5""W x 48""L, Sterile, Extended Field Ultrasound Probe Cover with 2 Elastics, Rolled "
2018-02-28
Sheathes - "Latex-Free, 1""D Tapered to 3""W x 96""L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Custom Tip, Telescopically Folded"
2018-03-07
Sheathes3D - "Seamless Viral Barrier Box End, Polyurethane, 1"" x 2.9"" Face to 4.5""W x 12""L, Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel & 2 Elastics, Rolled"
2018-07-27