FDA.reportPublic FDA data

n/a

Primary DI
E0HM39HI0731
Brand
n/a
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
HI073
Catalog number
HI073
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM39HI0731PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E0HM210023R2040181n/aHM23R 018500 204 194 006 0182026-08-17
E0HM25251GM1040601n/aHM251GM 060500 104 274 191 0602026-08-17
E0HM25251SX1040601n/aHM251SX 060500 104 274 224 0602026-08-17
E0HM29001912040051n/aHM191 005HM191 0052026-08-17
E0HM29001912040141n/aHM191 014HM191 0142026-08-17
E0HM72C703LHP1n/aC703LHPC703LHP2025-01-15
E0HM74MOD021n/aMOD02MOD022026-03-18
E0HM21000212040141n/aHM21 0145002041070060142026-07-24
E0HM22000013160121n/aHM1 0125003160010010122026-07-24
E0HM22000013160161n/aHM1 0165003160010010162026-07-24
E0HM22000013160211n/aHM1 0215003160010010212026-07-24
E0HM25079FX1040401n/aHM79FX 0405001041941400402026-07-24
E0HM39MI2071Bone ManagementMI207MI2072026-07-24
E0HM39MI2081Bone ManagementMI208MI2082026-07-24
E0HM72C0039HP1n/aC0039HPC0039HP2026-07-24
E0HM72C0060HP1n/aC0060HPC0060HP2026-07-24
EDRS220011OKTAGON Dental Implant BL RC22001220012015-10-01
EDRS220021OKTAGON Dental Implant BL RC22002220022015-10-01
EDRS220031OKTAGON Dental Implant BL RC22003220032015-10-01
EDRS220041OKTAGON Dental Implant BL RC22004220042015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431020MillenniumAvalign Technologies, Inc.HWM2026-09-18
00190776429089MillenniumAvalign Technologies, Inc.HWM2026-09-04
00190776429096MillenniumAvalign Technologies, Inc.HWM2026-09-04
00810111227360OsteotomeTreace Medical Concepts, Inc.HWM2026-08-25
00190776425807MillenniumAvalign Technologies, Inc.HWM2026-08-17
10705034579887N/AMedos International SàrlHWM2026-08-14
10705034579894N/AMedos International SàrlHWM2026-08-14
00190776424459MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424466MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424473MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776422738MillenniumAvalign Technologies, Inc.HWM2026-08-03
07640221373663SCALASpineArt SAHWM2026-07-24
07640221373670SCALASpineArt SAHWM2026-07-24
00190776421861MillenniumAvalign Technologies, Inc.HWM2026-07-23
00190776400422MillenniumAvalign Technologies, Inc.HWM2026-07-17
00190776400439MillenniumAvalign Technologies, Inc.HWM2026-07-17
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
00810143904666SURGIPROSSurgipros, LLCHWM2026-06-01
00810143904673SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907261SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907278SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907308SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907315SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01