FDA.report

Medartis

Primary DI
B504OMA39370
Brand
Medartis
Company
Provision
Model
A-3937
Published
2024-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWWCountersink

Product Code Classifications

CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B504OMA39370PrimaryHIBCC0

GMDN Terms

TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags

DUNS number
016889401
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504OM17090127YGS0Zimmer17090127YGS2025-09-03
B504OM0145080Smith and Nephew0145082025-06-19
B504OM254400111D0DePuy Mitek2544-00-111-D2025-06-10
B504OM254400111P0DePuy Mitek2544-00-111-P2025-06-10
B504AS35ULTSTZZ0Conmed Linvatec35ULT-ST-ZZ2017-12-01
B504AS42FRRRAZZ0Conmed Linvatec42FRR-RA-ZZ2017-12-01
B504AS9247A0Conmed Linvatec9247A2017-12-01
B504AS9297A0Conmed Linvatec9297A2017-12-01
B504AS9299A0Conmed Linvatec9299A2017-12-01
B504AS9399A0Conmed Linvatec9399A2017-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07
04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277390072MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
00810074306232Small Cannulated Countersink AO 125mmOsteocentric Technologies, Inc.HWW2024-12-06
00810111223416Depth gauge countersinkTreace Medical Concepts, Inc.HWW2024-11-19
04048266076830N/AMerete GmbHHWW2024-10-18
07612334236654NASynthes GmbHHWW2024-10-09
08800089451128Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHWW2024-09-25
00889795137098Phantom® Fibula Nail SystemPARAGON 28, INC.HWW2024-09-24
B504OM45300070StrykerProvisionHWW2024-08-26
B504OMAR8943050ArthrexProvisionHWW2024-08-13
B504OM127000040Extremity MedicalProvisionHWW2024-08-12
008100283950772.0/2.4 CountersinkTrilliant Surgical, LLCHWW2024-06-07
008100283950843.0/4.0 CountersinkTrilliant Surgical, LLCHWW2024-06-07
B504OM3108900SynthesProvisionHWW2024-05-17
B504OMP06N07110In2BonesProvisionHWW2024-05-17
B504OMP2091030000Paragon 28ProvisionHWW2024-05-17
B504OMA39380MedartisProvisionHWW2024-05-13
B504OM3109710SynthesProvisionHWW2024-05-06
05055662969818COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHWW2024-04-01
B504OMHSINK350TriMedProvisionHWW2024-03-28
08800089445516Surgical InstrumentJeil Medical CorporationHWW2024-03-19
00840118125000Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONHWW2024-02-19