Sheathes3D
GUDID 10842418102160
Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 5" Debris Shield, Vaginal/Rectal, Tapered, Bi-Directionally Rolled
SHEATHING TECHNOLOGIES, INC.
Body-orifice ultrasound imaging transducer cover, basic| Primary Device ID | 10842418102160 |
| NIH Device Record Key | b127c2c2-a58d-4dec-b6ed-7e739909d082 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sheathes3D |
| Version Model Number | 73540 |
| 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 | 00842418102163 [Unit of Use] |
| GS1 | 10842418102160 [Primary] |
| GS1 | 20842418102167 [Package] Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153212
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 | 2017-10-19 |
On-Brand Devices [Sheathes3D]
| 10842418104188 | Seamless Viral Barrier Contour "Hockey Stick" End, Latex-Free, 1.5" x 0.5" Face to 4"W x 48"L, S |
| 00842418104433 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 72"L (2.5cm x 8.1cm Face t |
| 20842418104420 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 58"L (2.5cm x 8.1 |
| 10842418104416 | Seamless Viral Barrier Adhesive Box End, Latex-Free, 1" x 3.2" Face to 6"W x 72"L, Sterile, Exte |
| 00842418104402 | Seamless Viral Barrier Contour Curved End, Polyurethane, 1" x 3" Face to 6"W x 72", Sterile, Ext |
| 20842418104390 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1 |
| 20842418104376 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1 |
| 20842418104369 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1 |
| 20842418104345 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face t |
| 20842418104338 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face t |
| 20842418104321 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face t |
| 20842418104475 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Extended Field Ultra |
| 20842418104383 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1 |
| 20842418104499 | 5-357-IL726 Sheathes3D Seamless Viral Barrier, Latex-Free, 1" x 3.2" Face to 6"W x 72"L & 5.5"W |
| 20842418104642 | 5-1245-IL4845, Bag, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L Ultrasound Probe Cover with a 4 |
| 20842418104635 | 5-1245-IL726, Bag, Polyurethane, 1"x 3.2" Face to 6"W x 72"L Ultrasound Probe Cover with a 4.5"W |
| 20842418104628 | 5-357-IL586, Bag, Polyurethane, 1" x 3.2" Face to 6"W x 58"L, Probe Cover with a 5.5"W x 12"L Ul |
| 20842418104611 | 5-1245-IL586, Bag, Polyurethane, 1" x 3.2" Face to 6"W x 58"L, Probe Cover with a 4.5"W x 12"L U |
| 20842418104604 | 5-357-IL486, Bag, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Probe Cover with a 5.5"W x 12"L Ul |
| 20842418104598 | 5-1245-IL486, Bag, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Probe Cover with a 4.5"W x 12"L U |
| 20842418104581 | 5-357-IH726, Bag, Polyurethane, 1"x 3" Face to 6"W x 72"L Ultrasound Probe Cover with a 5.5"W x |
| 20842418104574 | 5-1245-IH726, Bag, Polyurethane, 1"x 3" Face to 6"W x 72"L Ultrasound Probe Cover with a 4.5"W |
| 20842418104567 | 5-357-IH586, Bag, Polyurethane, 1"x 3" Face to 6"W x 58"L Ultrasound Probe Cover with a 5.5"W x |
| 20842418104550 | 5-1245-IH586, Bag, Polyurethane, 1"x 3" Face to 6"W x 58"L Ultrasound Probe Cover with a 4.5"W x |
| 20842418104543 | 5-357-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 5.5"W x 12"L Ultras |
| 20842418104536 | 5-1245-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 4.5"W x 12"L Ultra |
| 20842418102310 | Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 8"L, Sterile, Ultrasound Probe Cove |
| 20842418102303 | Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Debris |
| 20842418102297 | Seamless Viral Barrier, Latex-Free, 1.18"D x 9"L, Sterile, Ultrasound Probe Cover, Vaginal/Recta |
| 20842418102280 | Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Debris |
| 20842418102259 | Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Sterile, Extended Field Ultra |
| 10842418102160 | Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 5" Debris |
| 10842418102115 | Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, S |
| 20842418100989 | Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe |
| 20842418100934 | Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 El |
| 20842418100903 | Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 El |
| 20842418104307 | Seamless Viral Barrier Adhesive Patch, Latex-Free, 1.5"W x 4.5"L on 3"W x 5"L, Sterile, Ultrasou |
| 20842418104154 | Seamless Viral Barrier Adhesive End, Polyurethane, 2.25" x 1.1" Face x 12"L, Sterile, Specialty |
| 10842418104126 | Seamless Viral Barrier Contour Curved End, Latex-Free, 1"x 3" Face to 6"W x 96"L, Non-sterile, E |
| 20842418104109 | Seamless Viral Barrier Adhesive Box End, Latex-Free, 1" x 3.2" Face to 6"W x 72"L, Sterile, Exte |
| 20842418103997 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L, Sterile, |
| 20842418103812 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L, Sterile, Ex |
| 20842418103805 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Sterile, Ex |
| 20842418103799 | Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 96"L, Sterile, |
| 20842418103782 | Seamless Viral Barrier Contour T-End, Polyurethane, 2.1" x 0.5" Face to 6"W x 96”L, Sterile, E |
| 20842418103775 | Seamless Viral Barrier Contour T-End, Polyurethane, 2.1" x 0.5" Face to 4"W x 96"L, Sterile, Ext |
| 20842418103768 | Seamless Viral Barrier Contour "Hockey Stick" End, Polyurethane, 1.5" x 0.5" Face to 6"W x 96"L, |
| 20842418103751 | Seamless Viral Barrier Contour "Hockey Stick" End, Polyurethane, 1.5" x 0.5" Face to 4"W x 96"L, |
| 20842418103744 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L, Sterile, Extended Fi |
| 20842418103737 | Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 4.5"W x 96"L, Sterile, Extended |
Trademark Results [Sheathes3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHEATHES3D 86949262 5068397 Live/Registered |
Sheathing Technologies, Inc 2016-03-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.