FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704266474
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN013463
Catalog number
KM42825P
Device description
STYLETS ONLY FOR KM 42-825
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704266470Direct MarkingGS10
24026704266474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704266470040267042664704026704266470
2402670426647424026704266474

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663192873Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192897Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
00873263009314Visualase Neuro AccessoriesFHC, INC.GAH2025-12-12
00873263009338Visualase MR Stiffening StyletFHC, INC.GAH2025-12-12
03662663131414Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131506Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131513Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
08809204330522LIONHans Biomed Corp.GAH2025-11-26
08809204330539LIONHans Biomed Corp.GAH2025-11-26
08809204330546LIONHans Biomed Corp.GAH2025-11-26
08809204330553LIONHans Biomed Corp.GAH2025-11-26
08809204330560LIONHans Biomed Corp.GAH2025-11-26
08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809204330652LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009079Visualase MR Stiffening StyletFHC, INC.GAH2025-03-10