FDA.report

TBS BASICS

Primary DI
G149TBSB7880
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB788
Catalog number
TBSB788
Device description
TBS BASICS Mini Bone File, #9 Hollow Handle
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

Related Records

Product Codes

CodeName
GFIOsteotome, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G149TBSB7880PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

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

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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

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