Sheathes3D

GUDID 20842418104390

Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face to 15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5, & 2.0cm) & Adapter, Tilt-Out Style

SHEATHING TECHNOLOGIES, INC.

Ultrasound/electromagnetic-guided needle kit
Primary Device ID20842418104390
NIH Device Record Key54fb1b0f-fb96-423f-8e46-ddff26b48761
Commercial Distribution StatusIn Commercial Distribution
Brand NameSheathes3D
Version Model NumberADH-65-IL966-22110-3
Company DUNS806806220
Company NameSHEATHING TECHNOLOGIES, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842418104396 [Unit of Use]
GS110842418104393 [Primary]
GS120842418104390 [Package]
Contains: 10842418104393
Package: Case [3 Units]
In Commercial Distribution

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-22
Device Publish Date2020-12-14

On-Brand Devices [Sheathes3D]

10842418104188Seamless Viral Barrier Contour "Hockey Stick" End, Latex-Free, 1.5" x 0.5" Face to 4"W x 48"L, S
00842418104433Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 72"L (2.5cm x 8.1cm Face t
20842418104420Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 58"L (2.5cm x 8.1
10842418104416Seamless Viral Barrier Adhesive Box End, Latex-Free, 1" x 3.2" Face to 6"W x 72"L, Sterile, Exte
00842418104402Seamless Viral Barrier Contour Curved End, Polyurethane, 1" x 3" Face to 6"W x 72", Sterile, Ext
20842418104390Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1
20842418104376Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1
20842418104369Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1
20842418104345Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face t
20842418104338Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face t
20842418104321Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face t
20842418104475Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Extended Field Ultra
20842418104383Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1
208424181044995-357-IL726 Sheathes3D Seamless Viral Barrier, Latex-Free, 1" x 3.2" Face to 6"W x 72"L & 5.5"W
208424181046425-1245-IL4845, Bag, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L Ultrasound Probe Cover with a 4
208424181046355-1245-IL726, Bag, Polyurethane, 1"x 3.2" Face to 6"W x 72"L Ultrasound Probe Cover with a 4.5"W
208424181046285-357-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
208424181046115-1245-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
208424181046045-357-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
208424181045985-1245-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
208424181045815-357-IH726, Bag, Polyurethane, 1"x 3" Face to 6"W x 72"L Ultrasound Probe Cover with a 5.5"W x
208424181045745-1245-IH726, Bag, Polyurethane, 1"x 3" Face to 6"W x 72"L Ultrasound Probe Cover with a 4.5"W
208424181045675-357-IH586, Bag, Polyurethane, 1"x 3" Face to 6"W x 58"L Ultrasound Probe Cover with a 5.5"W x
208424181045505-1245-IH586, Bag, Polyurethane, 1"x 3" Face to 6"W x 58"L Ultrasound Probe Cover with a 4.5"W x
208424181045435-357-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 5.5"W x 12"L Ultras
208424181045365-1245-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 4.5"W x 12"L Ultra
20842418102310Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 8"L, Sterile, Ultrasound Probe Cove
20842418102303Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Debris
20842418102297Seamless Viral Barrier, Latex-Free, 1.18"D x 9"L, Sterile, Ultrasound Probe Cover, Vaginal/Recta
20842418102280Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Debris
20842418102259Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Sterile, Extended Field Ultra
10842418102160Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 5" Debris
10842418102115Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, S
20842418100989Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe
20842418100934Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 El
20842418100903Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 El
20842418104307Seamless Viral Barrier Adhesive Patch, Latex-Free, 1.5"W x 4.5"L on 3"W x 5"L, Sterile, Ultrasou
20842418104154Seamless Viral Barrier Adhesive End, Polyurethane, 2.25" x 1.1" Face x 12"L, Sterile, Specialty
10842418104126Seamless Viral Barrier Contour Curved End, Latex-Free, 1"x 3" Face to 6"W x 96"L, Non-sterile, E
20842418104109Seamless Viral Barrier Adhesive Box End, Latex-Free, 1" x 3.2" Face to 6"W x 72"L, Sterile, Exte
20842418103997Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L, Sterile,
20842418103812Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L, Sterile, Ex
20842418103805Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Sterile, Ex
20842418103799Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 2.9" Face to 4.5"W x 96"L, Sterile,
20842418103782Seamless Viral Barrier Contour T-End, Polyurethane, 2.1" x 0.5" Face to 6"W x 96”L, Sterile, E
20842418103775Seamless Viral Barrier Contour T-End, Polyurethane, 2.1" x 0.5" Face to 4"W x 96"L, Sterile, Ext
20842418103768Seamless Viral Barrier Contour "Hockey Stick" End, Polyurethane, 1.5" x 0.5" Face to 6"W x 96"L,
20842418103751Seamless Viral Barrier Contour "Hockey Stick" End, Polyurethane, 1.5" x 0.5" Face to 4"W x 96"L,
20842418103744Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L, Sterile, Extended Fi
20842418103737Seamless 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
SHEATHES3D
86949262 5068397 Live/Registered
Sheathing Technologies, Inc
2016-03-22

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