FDA.report

KMEDIC

Primary DI
24026704279306
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014588
Catalog number
KM48372
Device description
WIRE AND PIN BENDER 6" 3.2 MILLIMETER (1/8")
Published
2018-09-15
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
HXWBENDER

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704279302Direct MarkingGS10
24026704279306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704279302040267042793024026704279302
2402670427930624026704279306

GMDN Terms

TermDefinition
Orthopaedic wire crimperA hand-held manual surgical instrument designed like wire-closing forceps and used to bend wire or cerclage. This is a reusable device.

Device Sizes

TypeValueUnit
Length15Centimeter

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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