FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515115903
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
65-9205
Catalog number
65-9205
Device description
Spatula, endarterectomy
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
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515115903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515115903008885151159038885151159030888515115903

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
B382SD571002EM0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
B382SD572425E0Surgical DirectSurgical Direct, Inc.GAF2025-10-06
00810158217263PRINCETONPrinceton Medical Group, Inc.GAF2025-09-25
04250676741431SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741448SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
04250676741455SpatulaSpiggle & Theis Medizintechnik GmbHGAF2025-09-24
B382SD915095450Surgical DirectSurgical Direct, Inc.GAF2025-08-11
00840343725792GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725808GEN2SURGIX MEDICAL LLCGAF2025-06-16
00840343725815GEN2SURGIX MEDICAL LLCGAF2025-06-16
10649111448614Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
50649111448612Sklar InstrumentsSKLAR CORPORATIONGAF2025-05-29
B382SD915039100Surgical DirectSurgical Direct, Inc.GAF2025-05-19