Sheathes
GUDID 20842418100620
Polyurethane, 7/8"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Narrow, Bi-Directionally Rolled
SHEATHING TECHNOLOGIES, INC.
Body-orifice ultrasound imaging transducer cover, basic| Primary Device ID | 20842418100620 |
| NIH Device Record Key | f82e9e78-4144-4e81-b60f-84118588a8f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sheathes |
| Version Model Number | 40540 |
| Company DUNS | 806806220 |
| Company Name | SHEATHING TECHNOLOGIES, INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842418100626 [Unit of Use] |
| GS1 | 10842418100623 [Primary] |
| GS1 | 20842418100620 [Package] Contains: 10842418100623 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990175
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Sheathes]
| 00842418101838 | Polyurethane, 5"W x 48"L, Non-Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elast |
| 40842418100471 | Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, V |
| 30842418100474 | Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, V |
| 20842418104161 | Ultrasound Probe Cover In Microbial Barrier, Pre-gelled, 1"x11.8", Latex Free, Straight, Extra L |
| 10842418104201 | Polyurethane Ultrasound Probe Cover In Microbial Barrier, Pre-gelled, 1"x11.8", Latex Free, Tape |
| 20842418104222 | Polyurethane, 5.5"W x 12"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Rolled, Individu |
| 20842418104291 | Latex-Free, 5.5"W x 13"L , Non-Sterile, Extended Field Ultrasound Probe & Cord Cover, Rolled |
| 20842418104284 | Latex-Free, 6"W x 16", Non-Sterile, Extended Field Ultrasound Probe & Cord Cover, Rolled |
| 00842418104464 | Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile |
| 20842418104451 | Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile |
| 20842418104444 | Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile |
| 20842418104352 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face t |
| 00842418104211 | Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile |
| 20842418104253 | Polyurethane, 6"W x 36"L, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled |
| 20842418100118 | Latex, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, |
| 20842418104529 | 5-357-726, Bag, Sheathes, Polyurethane, 6"W x 72"L Ultrasound Probe Cover with a 5.5"W x 12"L Ul |
| 20842418104512 | 5-357-586, Bag, Sheathes, Polyurethane, 6"W x 58"L Ultrasound Probe Cover with a 5.5"W x 12"L Ul |
| 20842418104505 | 5-357-486, Bag, Sheathes, Polyurethane, 6"W x 48"L Ultrasound Probe Cover with a 5.5"W x 12"L U |
| 20842418104093 | Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile G |
| 10842418104089 | Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile G |
| 20842418104079 | Polyurethane, 7/8"D Tapered to 4"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover |
| 10842418103877 | Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, V |
| 20842418103447 | Polyurethane, 1"D Tapered to 3"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover w |
| 20842418103430 | Polyurethane, 1"D Tip to 2"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with |
| 20842418103331 | Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Sterile, Extended Field |
| 20842418103164 | Polyurethane, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 5" Debris Shield, 20ml Sterile Gel |
| 20842418103157 | Polyurethane, 1"D x 12"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vag |
| 20842418103140 | Polyurethane, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vagi |
| 20842418103133 | Polyurethane, 7/8"D x 8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Va |
| 20842418103126 | 5-40040 |
| 20842418102952 | Polyurethane, 1"D Tip to 2"W x 30"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with |
| 10842418102948 | Polyurethane, 7/8"D Tapered to 4"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover |
| 20842418102938 | Polyurethane, 1"D x 12"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vag |
| 20842418102921 | Polyurethane, 1"D x 9"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vagi |
| 20842418102853 | Polyurethane, 1"D Tapered to 3"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover w |
| 20842418102792 | Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rec |
| 20842418102785 | Latex, 7/8"D x 8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/R |
| 20842418102778 | Latex, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vagi |
| 20842418102761 | Latex, 1.25"D x 8"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/ |
| 20842418102419 | Latex-Free, 1"D Tapered to 3"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover wit |
| 20842418102341 | Latex-Free, 1"D Tapered to 4"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover wit |
| 20842418101900 | Polyurethane, 1"D x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, |
| 20842418101689 | Polyurethane, 1"D x 30"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, |
| 20842418101672 | Polyurethane, 7/8"D Tapered to 4"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover |
| 20842418101665 | Polyurethane, 7/8"D Tapered to 4"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover |
| 20842418101658 | Polyurethane, 7/8"D Tapered to 4"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover |
| 20842418101641 | Polyurethane, 1"D Tapered to 4"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover w |
| 20842418100743 | Polyurethane, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 5" Debris Shield and 1 Elastic, Va |
| 20842418100699 | Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tape |
| 20842418100668 | Polyurethane, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered |
Trademark Results [Sheathes]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHEATHES 88185222 not registered Dead/Abandoned |
Sheathing Technologies, Inc. 2018-11-07 |
 SHEATHES 74360846 not registered Dead/Abandoned |
Polayes, Lawrence S. 1993-02-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.