FDA.reportPublic FDA data

ELMED

Primary DI
00842180160040
Brand
ELMED
Company
ELMED INCORPORATED
Model
23-71362106
Catalog number
23-71362106
Device description
MALLET, 2LB OVERALL WEIGHT, WOODEN STYLE HANDLE, 38MM ROUND HEAD - 88.88 LONG, 8.3CM SHAFT (12.7MM ROUND), STAINLESS STEEL HEAD
Published
2023-01-18
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
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
00842180160040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180160040008421801600408421801600400842180160040

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
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
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
00842180179219ELMED569556952023-10-05
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423582MillenniumAvalign Technologies, Inc.GFJ2026-08-07
00190776423599MillenniumAvalign Technologies, Inc.GFJ2026-08-07
G22315466860Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGFJ2026-07-27
G149TBSB71200TBS BASICSACME ENTERPRISE.GFJ2026-05-22
05055445941086SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941093SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941109SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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
05055445941161SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941178SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941185SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941192SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941208SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941215SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941222SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941239SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941246SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941253SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941260SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941277SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
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