FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613086114
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
16-5177-L-R
Device description
Fine/Nagahara & Nichamin I Quick Chopper, Titanium, Left Hand Dominant, Use In Right Hand, Fine Interior Cutting Edge, Blunt Tip/Wedge Shaped Cutting Edge, Angled 10mm Bend toTip, Round Handle, 5-1/2" (134mm)
Published
2025-08-01
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

Related Records

Contact Domains

Product Codes

CodeName
HNQHook, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613086114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613086114001946130861141946130861140194613086114

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags

DUNS number
556623486
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

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00194613000028MSI Precision Specialty InstrumentsCA10202025-08-01
00194613000059MSI Precision Specialty InstrumentsCA10502025-08-01
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00194613000264MSI Precision Specialty InstrumentsCA12PK-302025-08-01
00194613000332MSI Precision Specialty InstrumentsCA19102025-08-01
00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
00194613000462MSI Precision Specialty InstrumentsCA20402025-08-01
00194613000509MSI Precision Specialty InstrumentsCA20802025-08-01
00194613000639MSI Precision Specialty InstrumentsCA22102025-08-01
00194613000707MSI Precision Specialty InstrumentsCA22802025-08-01
00194613000769MSI Precision Specialty InstrumentsCA23402025-08-01
00194613000806MSI Precision Specialty InstrumentsCA23702025-08-01
00194613000813MSI Precision Specialty InstrumentsCA23802025-08-01
00194613000912MSI Precision Specialty InstrumentsCA24702025-08-01
00194613000943MSI Precision Specialty InstrumentsCA25002025-08-01
00194613000950MSI Precision Specialty InstrumentsCA2500-1.5-902025-08-01

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