FDA.report

ORTHOMED

Primary DI
B8034907600
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 49-0760
Device description
COLLIN MALLET 8" 7 OZ./ 5 OZ.
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GFJMallet, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B8034907600PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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B8035202020ORTHOMEDOM 52-02022026-02-18
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B8035202060ORTHOMEDOM 52-02062026-02-18
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B8035105320ORTHOMEDOM 51-05322026-02-09
B8035105340ORTHOMEDOM 51-05342026-02-09

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