FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613111069
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
M14200
Device description
Novo Phenolic Mallet Extra Large, Overall Length 10 3/8" (263.5mm) Handle Length To Head Is 8 3/8" (213.0mm) Overall Head Width 3.43" (87mm) By 2" (50.5mm), Vertical Cylinder Shape Head, Overall Weight Of Mallet Is 12.3 Ounces With A Large Grooved Round Smooth Style Grip Handle_x000D_
Published
2025-03-21
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

Product Codes

CodeName
HXLMALLET

Product Code Classifications

CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613111069PrimaryGS10

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

Contacts

PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags

DUNS number
556623486
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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00194613000264MSI Precision Specialty InstrumentsCA12PK-302025-08-01
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00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
00194613000462MSI Precision Specialty InstrumentsCA20402025-08-01
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00194613000813MSI Precision Specialty InstrumentsCA23802025-08-01
00194613000912MSI Precision Specialty InstrumentsCA24702025-08-01
00194613000943MSI Precision Specialty InstrumentsCA25002025-08-01
00194613000950MSI Precision Specialty InstrumentsCA2500-1.5-902025-08-01

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