DEVICE: MSI Precision Specialty Instruments (00194613108427)

Device Identifier (DI) Information

MSI Precision Specialty Instruments
M10000
In Commercial Distribution

Med Saver, Inc.
00194613108427
GS1

1
556623486 *Terms of Use
Doyen Medium Mallet With Bullet Shaped Head, Overall Length 7 5/8" (194mm) Handle Length To Head Is 6 5/8" (170mm) Overall Head Width 43.8mm Long, One Side of Head IS A flat surface With Head Diameter 29.4mm The Other Side Is Convexed With Head Diameter Of 21.4mm, Overall Weight Of Mallet Is 5.9 Ounces With A Smooth Style Grip Handle_x000D_
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32312 Surgical mallet
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HXL MALLET
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8736c648-0a09-428c-9118-b2049643bd62
March 31, 2025
1
March 21, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(610)935-8181
sales@msiprecision.com
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