FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515243446
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-5626
Catalog number
93-5626
Device description
Ostrum Antrum Punch, left
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAWPUNCH, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAWPunch, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515243446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515243446008885152434468885152434460888515243446

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
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
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530730BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00840183530747BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00194613011499MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029326MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029364MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047214MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047221MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613061739MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081393MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081447MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081508MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081560MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613085568MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613088842MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613091507MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613094720MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613095062MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102104MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102111MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613106171MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613123765MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00757770508563Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508624Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508655Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508679Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00840183530426BR Surgical, LLCBR Surgical, LLCKAW2025-06-26
00840183530433BR Surgical, LLCBR Surgical, LLCKAW2025-06-26
00194613029319MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-03-21
00194613029333MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-03-21
00194613029357MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-03-21