Vashe Sterile Sleeve

Primary DI
10190769003552
Brand
Vashe Sterile Sleeve
Company
URGO MEDICAL NORTH AMERICA, LLC
Model
00355
Catalog number
00355
Device description
The Vashe Sterile Sleeve is an optional accessory for Vashe Wound Solution. The Sleeve is a sterile drape fitted with a spiked cap and nozzle tip. The Sleeve can be aseptically fitted over an instillation bottle of Vashe Wound Solution to render the outside of the bottle sterile so it may be brought into a sterile field. The spiked cap is aseptically pushed through the septum cap of the bottle, and the sterile splash guard placed over the nozzle tip.
Published
2017-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMWDrape, Microscope, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMWDrape, Microscope, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190769003552PackageGS112In Commercial Distribution
00190769003555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019076900355210190769003552
00190769003555001907690035551907690035550190769003555

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
817-885-8273info@steadmed.com

Regulatory Flags#

DUNS number
052758618
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851383003122Vashe Wound Solution 118 ml container - Flip Cap003122019-12-02
00851383003146Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container00314003142020-02-03
00851383003160Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container00316003162020-02-07
00851383003177Vashe Wound Solution 475 ml (16 fl oz) Instillation Container00317003172020-04-01
00851383003221Vashe Wound Solution 1 L (34 fl oz) Flip Top Container00322003222020-04-01
00851383003238Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container00323003232020-04-01
00851383003139Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap00313003132020-02-03
00851383003634Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap003602025-11-17
00190769003555Vashe Sterile Sleeve00355003552017-07-17
00190769003548Vashe Wipes Skin Cleansing Solution Kit00354003542018-03-28
00190769004057Vashe Wound Solution OTC00405004052021-12-07
00190769532437URGOK2 5532435532432019-12-26
00190769532468URGOK2 Lite 5532465532462019-12-20
00190769532444URGOK2 5532445532442019-12-20
00190769532451URGOK2 Lite 5532455532452019-12-20
00851383003528Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap00352003522020-02-03
00851383003214Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.3900321003212019-12-02
00851383003009Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300003002019-11-01
00851383003016Drawtex Hydroconductive Wound Dressing with LevaFiber 3X300301003012019-11-01
00851383003023Drawtex Hydroconductive Wound Dressing with LevaFiber 4X400302003022019-11-01

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