FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515208575
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
80-2165
Catalog number
80-2165
Device description
New Orleans Lens Loop
Published
2024-02-27
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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515208575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515208575008885152085758885152085750888515208575

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. 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
00724995275082V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275099V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275105V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275112V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275129V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293581V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293598V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293604V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293611V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306281V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306298V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306304V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00190776424121MillenniumAvalign Technologies, Inc.GZX2026-08-27
00190776420376MillenniumAvalign Technologies, Inc.GZX2026-08-25
00190776419134MillenniumAvalign Technologies, Inc.GZX2026-08-23
00190776427191MillenniumAvalign Technologies, Inc.GZX2026-08-21
00190776414672MillenniumAvalign Technologies, Inc.GZX2026-08-18
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407407MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20