FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515243552
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-5638
Catalog number
93-5638
Device description
Tobey Micro Backbiter, rotating, 110mm Shaft 1.8mm x 4.5mm
Published
2024-02-28
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
KTFPUNCH, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515243552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515243552008885152435528885152435520888515243552

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags#

DUNS number
848522678
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888515202146BOSS Instruments77-322077-32202024-02-28
00888515328037BOSS InstrumentsVSX233VSX2332025-10-28
00888515328044BOSS InstrumentsVSG511VSG5112025-10-28
00888515272026Stealth SurgicalSS3923SS39232016-10-01
00888515272040Stealth SurgicalSS3925SS39252016-10-01
00888515272064Stealth SurgicalSS3927SS39272016-10-01
00888515217515BOSS Instruments80-624080-62402024-02-28
00888515217522BOSS Instruments80-624280-62422024-02-28
00888515217539BOSS Instruments80-624480-62442024-02-28
00888515217546BOSS Instruments80-624680-62462024-02-28
00888515217553BOSS Instruments80-624880-62482024-02-28
00888515217560BOSS Instruments80-625080-62502024-02-28
00888515217577BOSS Instruments80-625280-62522024-02-28
00888515217584BOSS Instruments80-625380-62532024-02-28
00888515217591BOSS Instruments80-625480-62542024-02-28
00888515217638BOSS Instruments80-626080-62602024-02-28
00888515217645BOSS Instruments80-626180-62612024-02-28
00888515217683BOSS Instruments80-627080-62702024-02-28
00888515217690BOSS Instruments80-627580-62752024-02-28
00888515217706BOSS Instruments80-627880-62782024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417871MillenniumAvalign Technologies, Inc.KTF2026-03-11
04250676717351Kerrison rongeurSpiggle & Theis Medizintechnik GmbHKTF2025-09-25
00194613029340MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036331MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036355MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036379MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036386MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036393MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613111533MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613123741MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00190776402624MillenniumAvalign Technologies, Inc.KTF2025-06-24
00190776402433MillenniumAvalign Technologies, Inc.KTF2025-06-23
00192896121614Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2025-06-06
00190776394943MillenniumAvalign Technologies, Inc.KTF2025-05-08
00194613029395MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036324MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036348MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036362MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613082239MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613108045MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00192896120945Ostrum Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-12-10
00190776384913MillenniumAvalign Technologies, Inc.KTF2024-08-26
00192896119000Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00192896119024Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00887482118801Symmetry CarleyASPEN SURGICAL PRODUCTS, INC.KTF2024-08-20
00888515134003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242135BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242142BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242173BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515243507BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28