FDA.report

Henry Schein

Primary DI
00304040049136
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1048507
Catalog number
1048507
Device description
Nail Splitter 5" English
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FZTCUTTER, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040049136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040049136003040400491363040400491360304040049136

GMDN Terms

TermDefinition
Nail splitting scissorsA surgical instrument designed for the purpose of cutting and splitting a finger or toenail, typically for removal, during a surgical intervention. It comprises two pivoted blades with finger and thumb ring handles and is operated by forcing the lower blade under the nail to be cut and closing the blades together over the nail. This cutting blades are typically very short, pointed and robust. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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