FDA.reportPublic FDA data

KMEDIC

Primary DI
44026704722356
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014544
Catalog number
KM48302
Device description
BONE COMPASS 8"
Published
2024-02-16
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704722356Direct MarkingGS10
24026704278842PreviousGS10
14026704722355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670472235644026704722356
2402670427884224026704278842
1402670472235514026704722355

GMDN Terms#

Term, Definition table
TermDefinition
Manual goniometerA non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20.3Centimeter

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
false
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
G149TBSB7860TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7870TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7880TBS BASICSACME ENTERPRISE.GFI2026-05-22
10889981443764SpecialsSeaspine Orthopedics CorporationGFI2026-03-03
D9281051992HF0SINUS INSTRUMENT #2 HF D/EW.H. Holden, Inc.GFI2026-02-19
10889981441340SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441357SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441364SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441371SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
03662663220873Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220880Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220897Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
10889981440787SpecialsSeaspine Orthopedics CorporationGFI2026-01-07
03662663156783SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156790SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156806SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156813SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156820SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156837SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
00757770703708Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770703715Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770447046Bausch + LombBausch & Lomb IncorporatedGFI2025-12-11
00810207783312Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783329Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783336Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783343Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783350Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783367Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783374Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783381Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24