FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613100643
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
20109
Device description
Busin Glide Spatula, 16mm Donor Button, Insertion Plate Allows Incisions As Small As 3.2mm, For DSEK "Pull Through" Technique
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
HNDSpatula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613100643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613100643001946131006431946131006430194613100643

GMDN Terms

TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01
00194613000011MSI Precision Specialty InstrumentsCA10102025-08-01
00194613000028MSI Precision Specialty InstrumentsCA10202025-08-01
00194613000059MSI Precision Specialty InstrumentsCA10502025-08-01
00194613000080MSI Precision Specialty InstrumentsCA10702025-08-01
00194613000097MSI Precision Specialty InstrumentsCA10802025-08-01
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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