FDA.reportPublic FDA data

n/a

Primary DI
E0HM39BV0401
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
BV040
Catalog number
BV040
Device description
Manual instrument for dental/surgical application
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTTBURR, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM39BV0401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags#

DUNS number
318034329
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
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
E0HM266736436BE00101n/a6736-4366736-4362026-02-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390030001131Reprocessed 2.3mm Lindemann ReamerSURETEK MEDICALHTT2025-07-18
08057717551020SHANNON STD BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551082SHANNON ISHAM BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551143CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551204CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551266CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551327CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551389CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551457WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551525WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551587ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551648ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551709BROPHY BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717550962SHANNON SHORT BURRBRM EXTREMITIES SRLHTT2025-03-27
B504OM0228013S0BrasselerProvisionHTT2025-02-05
B504OM030000170SynthesProvisionHTT2025-02-05
B504OM030000700SynthesProvisionHTT2025-02-05
B504OM03228015S0BrasselerProvisionHTT2025-02-05
B504OM03228017S0BrasselerProvisionHTT2025-02-05
B504OM04C03060BrasselerProvisionHTT2024-08-08
B504OM5300107140StrykerProvisionHTT2024-08-08
B504OM5300309010StrykerProvisionHTT2024-08-08
B504OM58200800210StrykerProvisionHTT2024-08-08
00840124512801FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCHTT2024-06-27
B504OMAR300B1010ArthrexProvisionHTT2024-06-10
B504OM5300105070StrykerProvisionHTT2024-05-28
B504OM13750520ConMedProvisionHTT2024-05-22
B504OM13750530ConMedProvisionHTT2024-05-22
B504OMDW311055R0VilexProvisionHTT2024-05-22
B504OM50911020ConMedProvisionHTT2024-05-16