FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB71200
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB7120
Catalog number
TBSB7120
Device description
TBS BASICS Mallet with Plastic Inserts
Published
2026-05-22
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

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
G149TBSB71200PrimaryHIBCC0

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
645459892
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G149TBSB71000TBS BASICSTBSB7100TBSB71002026-05-22
G149TBSB71010TBS BASICSTBSB7101TBSB71012026-05-22
G149TBSB71020TBS BASICSTBSB7102TBSB71022026-05-22
G149TBSB71030TBS BASICSTBSB7103TBSB71032026-05-22
G149TBSB71040TBS BASICSTBSB7104TBSB71042026-05-22
G149TBSB71050TBS BASICSTBSB7105TBSB71052026-05-22
G149TBSB71060TBS BASICSTBSB7106TBSB71062026-05-22
G149TBSB71070TBS BASICSTBSB7107TBSB71072026-05-22
G149TBSB71080TBS BASICSTBSB7108TBSB71082026-05-22
G149TBSB71090TBS BASICSTBSB7109TBSB71092026-05-22
G149TBSB71100TBS BASICSTBSB7110TBSB71102026-05-22
G149TBSB71110TBS BASICSTBSB7111TBSB71112026-05-22
G149TBSB71120TBS BASICSTBSB7112TBSB71122026-05-22
G149TBSB71130TBS BASICSTBSB7113TBSB71132026-05-22
G149TBSB71140TBS BASICSTBSB7114TBSB71142026-05-22
G149TBSB71150TBS BASICSTBSB7115TBSB71152026-05-22
G149TBSB71160TBS BASICSTBSB7116TBSB71162026-05-22
G149TBSB71170TBS BASICSTBSB7117TBSB71172026-05-22
G149TBSB71180TBS BASICSTBSB7118TBSB71182026-05-22
G149TBSB71190TBS BASICSTBSB7119TBSB71192026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05055445941345SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941352SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941369SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12
05055445941376SurtexSURTEX INSTRUMENTS LTD.GFJ2026-05-12