FDA.report

KMEDIC

Primary DI
24026704285239
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015087
Catalog number
KM53316
Device description
GRADLE SCISSORS 3 3/4" SLIGHT CURVED SHARP/SHARP
Published
2018-09-15
Public version status
New
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
HRRSCISSORS, ORTHOPEDIC, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704285235Direct MarkingGS10
24026704285239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704285235040267042852354026704285235
2402670428523924026704285239

GMDN Terms

TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length9.5Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
true
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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