FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515200074
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
77-0687
Catalog number
77-0687
Device description
Fukuda Shoulder Ret, small
Published
2024-02-22
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
00888515200074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515200074008885152000748885152000740888515200074

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00190776400620MillenniumAvalign Technologies, Inc.GAD2026-07-19
00190776400330MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400361MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400453MillenniumAvalign Technologies, Inc.GAD2026-07-17
00198506039072ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092152ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092190ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092206ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092213ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092220ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092237ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092244ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092251ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092268ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092275ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092282ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092299ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092305ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092312ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092329ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092336ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092626ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00810220800454Adler Instrument CompanyAdler, Inc.GAD2026-07-17
04058749048186NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749049800NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749078008NAFehling Instruments GmbH & Co. KGGAD2026-07-17
B382SD907808200Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD907808210Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17