FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704278309
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014509
Catalog number
KM48239
Device description
MICHELE TREPHINE SMALL OUTSIDE DIAMETER 3/16"
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
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704278305Direct MarkingGS10
24026704278309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704278305040267042783054026704278305
2402670427830924026704278309

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Centimeter

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
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
10193489179583MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
10193489179590MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
00850055649705INTREPED Extraction KitAuxano Medical LLCHWK2025-01-10
00190776384609MillenniumAvalign Technologies, Inc.HWK2024-08-22
00190776384616MillenniumAvalign Technologies, Inc.HWK2024-08-22
B756STR00107SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21