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
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462912070evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912094evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912216evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912223evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912254evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912261evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912421evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912520evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912940evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912957evonosevonos GmbH & Co. KGGFI2026-08-19
04054462900305evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900312evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900329evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900336evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900343evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900350evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900367evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912087evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912100evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912131evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912148evonosevonos GmbH & Co. KGGFI2026-08-18
00841435123717TecometTECOMET INC.GFI2026-07-30
00841435123724TecometTECOMET INC.GFI2026-07-30
00841435123731TecometTECOMET INC.GFI2026-07-30
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
00841435123557TecometTECOMET INC.GFI2025-02-07
00841435123564TecometTECOMET INC.GFI2025-02-07
00841435123571TecometTECOMET INC.GFI2025-02-07
00841435121355TecometTECOMET INC.GFI2023-07-21
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03