FDA.report

n/a

Primary DI
E0HM39BKMMW1
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
BKMMW
Catalog number
BKMMW
Device description
Bone Mill
Published
2021-09-15
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

Related Records

Contact Domains

Product Codes

CodeName
LYSBone mill

Product Code Classifications

CodeDeviceSpecialtyClass
LYSBone MillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E0HM39BKMMW1PrimaryHIBCC0

GMDN Terms

TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags

DUNS number
318034329
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

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E0HM266736445BE00101n/a6736-4456736-4452026-02-04
E0HM266736454BE00101n/a6736-4546736-4542026-02-04
E0HM266736463BE00101n/a6736-4636736-4632026-02-04
E0HM2900560317005101n/aHM560 0055003171940060052026-02-04
E0HM39MU1860140021n/aMU186 002MU186 0022026-02-04
E0HM740IVK011n/aIVK01IVK012026-02-04
E0HM740IVK021n/aIVK01IVK012026-02-04
E0HM740IVK031n/aIVK01IVK012026-02-04
E0HM79BIE001Bone ManagementBIE00BIE002026-02-04
E0HMSAGE011n/aSAGE01SAGE012026-02-04
E0HM266735268BE00101n/a6735-2686735-2682025-07-11
E0HM266736230BE00101n/a6736-2306736-2302025-07-11
E0HM266736285BE00101n/a6736-2856736-2852025-07-11
E0HM266736338BE00101n/a6736-3386736-3382025-07-11
E0HM266736383BE00101n/a6736-3836736-3832025-07-11
E0HM39310540000001Bone Management31054310542025-07-11
E0HM39MSTDW1Bone ManagementMSTDWMSTDW2025-07-11
E0HM740SSA011n/aSSA01SSA012025-07-11
E0HM79WPP211n/aWPP21WPP212025-07-11

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04047844121368DIPLOMATSIGNUS Medizintechnik GmbHLYS2024-06-05
00842517106253Karl SchumacherKarl Schumacher Dental, LLCLYS2024-02-27
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00614950031252ACEACE SURGICAL SUPPLY CO., INC.LYS2023-12-05
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00190776264055AvalignAVALIGN TECHNOLOGIES, INC.LYS2023-06-23
08720254007816Sterilization tray NBMSpierings Orthopaedics B.V.LYS2023-06-20
08720254007823HousingSpierings Orthopaedics B.V.LYS2023-06-20
08720254007830Push BlockSpierings Orthopaedics B.V.LYS2023-06-20
08720254007847HandleSpierings Orthopaedics B.V.LYS2023-06-20
08720254007854Screw nutSpierings Orthopaedics B.V.LYS2023-06-20
08720254007861Milling Drum Extra Extra Extra FineSpierings Orthopaedics B.V.LYS2023-06-20