FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515243514
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-5634
Catalog number
93-5634
Device description
Micro Rotating Backbiter, ped
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
00888515243514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515243514008885152435148885152435140888515243514

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
04054462900404evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905829evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905843evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905850evonosevonos GmbH & Co. KGKTF2026-08-18
04054462908912evonosevonos GmbH & Co. KGKTF2026-08-18
04054462915163evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915170evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915187evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915194evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915200evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915217evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915224evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915231evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915248evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915255evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915262evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915279evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915286evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915293evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915309evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915316evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915323evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915347evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915354evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915361evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915378evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915385evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915392evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915408evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915415evonosevonos GmbH & Co. KGKTF2026-08-17