Henry Schein

Primary DI
00304040126653
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1046032
Catalog number
1046032
Device description
HSI Bouffant Cap Poly Blue
Published
2020-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXPCOVER, SHOE, OPERATING-ROOM

Product Code Classifications

CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040126650PrimaryGS10
00304040126653Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404012665010304040126650
00304040126653003040401266533040401266530304040126653

GMDN Terms

TermDefinition
Shoe cover, non-conductive, non-sterileA non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187647Zirlux920006392000632026-02-04
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