FDA.report

MedSource Yankaeur Tip Only, Vented

Primary DI
00816703021996
Brand
MedSource Yankaeur Tip Only, Vented
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-YK10
Device description
MedSource Yankaeur Tip Only, Vented
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816703021996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703021996008167030219968167030219960816703021996

GMDN Terms

TermDefinition
Electron beam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using electron beams (accelerated electrons). It typically includes a treatment chamber with shelves where packed devices to be sterilized are placed; an electron beam source; and controls to regulate the time of the procedure. The device is mainly used by manufacturers to irradiate single-use medical devices (e.g., syringes, needles) and supplies even after they are packed and ready to deliver; they may also be used in big healthcare facilities that sterilize a great volume of devices.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
041674552
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
true

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00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
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00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
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