FDA.report

Integra® Miltex®

Primary DI
H834402600
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
40-260
Catalog number
40-260
Device description
Ingrown Nail Splitting Scissors, 6-1/4"
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780500964PrimaryGS10
H834402600SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178050096410381780500964

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

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
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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