FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704282832
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014883
Catalog number
KM49848
Device description
ROD HOLDER 10" 5.0/5.5 MILLIMETER WITH PRISM
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704282838Direct MarkingGS10
24026704282832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704282838040267042828384026704282838
2402670428283224026704282832

GMDN Terms#

Term, Definition table
TermDefinition
Implant handling forceps, scissors-likeA hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter

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
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

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
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00840536800237Response Spine SystemORTHOPEDIATRICS CORP.HXW2026-01-15
00840180543283General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
00840180543290General InstrumentsALPHATEC SPINE, INC.HXW2025-12-31
10889981095987GeneralSeaspine Orthopedics CorporationHXW2025-12-19
03662663261869BacFix Ti Spinal Fixation SystemHighridge Medical, LLCHXW2025-12-18
00840194418140PediflexORTHOPEDIATRICS CORP.HXW2025-12-11
00840493413907RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413914RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413921RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413938RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00840493413945RIVA Posterior Fixation SystemXENIX MEDICAL LLCHXW2025-12-02
00199150044375Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
00199150044382Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2025-11-24
03662663153379Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153386Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153393Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663153409Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663191784Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214872Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214889Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663214896Vital Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-17
03662663146227Gallery Laminoplasty Fixation SystemHighridge Medical, LLCHXW2025-11-15
03662663113410Virage OCT Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663131995Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663132008Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXW2025-11-14
03662663136785Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136792Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14
03662663136808Polaris 4.75 Deformity SystemHighridge Medical, LLCHXW2025-11-14