FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613063443
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
5-3599
Device description
Wright Fascia Needle, Curved Shaft And Ring Handle With Polished Finish, 2mm Wide Tip, 1mm X 6mm Eye, And Overall Length Of 5 1/8" (130mm)
Published
2024-08-15
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
GEJCARRIER, LIGATURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613063443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613063443001946130634431946130634430194613063443

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482041451Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054918Symmetry SurgicalSYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054925Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00854037007170eXact Suture Placement DeviceCypris Medical, Inc.GEJ2024-06-10
00190776382711MillenniumAvalign Technologies, Inc.GEJ2024-05-06
00888515204522BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204539BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204591BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204607BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
G586UR6208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
G586UR96208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
00190776262549AvalignAvalign Technologies, Inc.GEJ2023-09-28
00840319750018Hayden MedicalHayden Medical, Inc.GEJ2023-03-21
00854037007149eXact 5.1Cypris Medical, Inc.GEJ2023-02-28
54026704788748PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
54026704811026PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
10885403133237V. MuellerCAREFUSION 2200, INCGEJ2022-11-27
00840306808111Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-21
00840306808142Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-14
00840306808319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-10
00840306808104Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808128Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808135Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840343713454GEN2SURGIX MEDICAL LLCGEJ2022-11-04
00840343713461GEN2SURGIX MEDICAL LLCGEJ2022-11-04
00840343700058Gen2SURGIX MEDICAL LLCGEJ2022-10-18