FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515117341
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
66-1554
Catalog number
66-1554
Device description
"Rumel Tourniquet, flex-neck obturator only, child Overall length 8 1/4"""
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515117341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515117341008885151173418885151173410888515117341

GMDN Terms#

Term, Definition table
TermDefinition
Ligature loop applierA hand-held manual surgical instrument designed for the application of a ligature loop (e.g., wire, suture, tubing) around a blood vessel, or other tissue, for occlusion during open surgery. It is typically a slender rod with a hook at the distal end; it does not include a ligature passing mechanism (i.e., not a passer). This is a reusable device intended to be sterilized prior to use.

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
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18