FDA.report

KMEDIC

Primary DI
24026704287486
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015304
Catalog number
KM55872
Device description
SPURLING-KERRISON PUNCH 8" 5 MILLIMETER FORWARD 15 MILLIMETER ORTHOPEDIC
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
HTXRONGEUR

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704287482Direct MarkingGS10
24026704287486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704287482040267042874824026704287482
2402670428748624026704287486

GMDN Terms

TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length20.5Centimeter

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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