FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515200296
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
77-0716
Catalog number
77-0716
Device description
Kolbel Retractor blade, 36 x 85mm, pair
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515200296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515200296008885152002968885152002960888515200296

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonThompson Surgical Instruments, Inc.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23