Sheathes Pre-Gelled

GUDID 20842418104192

Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Individually Wrapped

SHEATHING TECHNOLOGIES, INC.

Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel
Primary Device ID20842418104192
NIH Device Record Key09f440ba-8065-464a-a069-c7a945991f27
Commercial Distribution StatusIn Commercial Distribution
Brand NameSheathes Pre-Gelled
Version Model Number27085-P
Company DUNS806806220
Company NameSHEATHING TECHNOLOGIES, INC.
Device Count30
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
GS100842418104198 [Unit of Use]
GS110842418104195 [Primary]
GS120842418104192 [Package]
Contains: 10842418104195
Package: CASE [6 Units]
In Commercial Distribution

FDA Product Code

OIPRadiology-Diagnostic Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-08
Device Publish Date2019-04-30

On-Brand Devices [Sheathes Pre-Gelled]

20842418104192Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
20842418104260Pre-Gelled, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L Non-Sterile, Ultrasound Probe Cover, Vag
2084241810262450001-27964, Case, Polyurethane, 7/8"D Tapered to 4"W x 96"L, Non-Sterile, Pre-Gelled Extended F
20842418102617Polyurethane, 7/8"D Tapered to 4"W x 36"L, Non-Sterile, Pre-Gelled Extended Field Ultrasound Pro
20842418102587Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
20842418102570Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 5" Debris Shield, V
20842418102563Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 3" Debris Shield, V
20842418102532Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
20842418102525Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
20842418102518Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
20842418102501Polyurethane, 1"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tape
2084241810249527380-PT, Each, Polyurethane, 1"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Prove Cover, Vagi
20842418102488Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
20842418102471Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered

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