FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515310995
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
81-7070T
Catalog number
81-7070T
Device description
Seibel Nucleus Chopper, LH, Round Handle, DE, 5.5", Titanium
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNNKnife, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515310995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515310995008885153109958885153109950888515310995

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
00850072675008MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675015MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675022MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675053MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675060MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675077MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675084MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675114MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675121MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675138MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675145MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675152MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675169MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675176MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675183MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675190MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675206MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675220MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16