FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515243644
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
93-5646
Catalog number
93-5646
Device description
Strumpel Voss Fcps, up 90deg, sz 0
Published
2024-02-29
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
KAEFORCEPS, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515243644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515243644008885152436448885152436440888515243644

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
09348811103338INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-16
09348811103321INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-09
24026704934472PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934489PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934502PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934519PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934526PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934533PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934540PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934557PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934571PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934588PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934625PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934632PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
00810123209842Adler Instrument CompanyAdler, Inc.KAE2026-03-03
00190776417413MillenniumAvalign Technologies, Inc.KAE2026-02-27
00190776417468MillenniumAvalign Technologies, Inc.KAE2026-02-27
00848657078214AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
00848657078221AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
09008737448905SoftGrip Forceps 2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
09348811103659INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
09348811103673INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
04046826104276Medicon ForcepsMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2025-12-15
09348811105424INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811129017INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104229INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104328INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01