FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613005351
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
5-1961
Device description
Francis Spud, Flat Shaped Sharp Tip, Flat Handle, Polished Finish, Overall Length 4-3/4" (120mm)
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
HNASpud, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613005351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613005351001946130053511946130053510194613005351

GMDN Terms

TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. 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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00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
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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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