FDA.reportPublic FDA data

Mallet

Primary DI
08056992093058
Brand
Mallet
Company
MC BIO SRL
Model
9100340
Device description
Stainless steel mallet
Published
2025-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFJMallet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFJMallet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056992093058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056992093058080569920930588056992093058

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

Regulatory Flags#

DUNS number
338319497
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057639710567Specialist Organizer95708882025-06-23
08057639710574Tip with Indexable Stop95705662025-06-23
08057639710598Offset Tip SP95708602025-06-23
08057639710604Long Tip SP95705672025-06-23
08057639710628GBR MODULAR SET95753102025-06-23
080576397106355 Scraper box95725102025-06-23
08057639711960G-Special box95708902025-06-23
08057639711977Modular Box95745722025-06-23
08057639711984MT Tack organizer95744502025-06-23
08057639711991GBR Academia box95709002025-06-23
08057639712004Asymmetric Scraper box95753002025-06-23
08057639712011Straight Scraper Box95752302025-06-23
080576397120287 Scraper box95750802025-06-23
08057639712035Supertack box95705902025-06-23
08057639712042MC BIO Tack organizer95705702025-06-23
08057639712059Tuff Tack Box95705962025-06-23
08057639712066Handle - Straight MDF388502025-06-23
08057639712073Handle - Straight - Ergal303322025-06-23
08057639712080Handle - Straight SP (TiN)305482025-06-23
08057639712097Handle - Asym. - Ergal380462025-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055445941116SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941123SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941130SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941147SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941154SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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05055445941239SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941260SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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05055445941284SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941291SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941307SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941314SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941321SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941338SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941345SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941352SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941369SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12