FDA.report

KMEDIC

Primary DI
24026704288995
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015440
Catalog number
KM58112
Device description
KIRMISSION RASP 6 3/4"
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
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704288991Direct MarkingGS10
24026704288995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704288991040267042889914026704288991
2402670428899524026704288995

GMDN Terms

TermDefinition
Rib raspatoryA hand-held, manually-operated, surgical instrument with a profiled, forward-scraping edge (sharp or blunt, sometimes double-sided) used to elevate and/or detach rib periosteum (membrane of fibrous connective tissue) from the underlying bone by a pushing action usually applied along the longitudinal axis of the bone. It is typically a one-piece instrument made of high-grade stainless steel; it is available in a variety of sizes and blade designs (e.g., long shaft-like blades that terminate in right-angles, scythe-like blades that fit over the rib bone, or robust blades that may be notched or curved), and may be used for rib-like bones (e.g., clavicle, fibula). This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length17.1Centimeter

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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