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, Ring Handle, Polished Finish, 2mm Wide Tip, 1mm X 6mm Eye, Overall Length 5-1/8"" (130mm)"
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194613017279MSI Precision Specialty InstrumentsE53772025-08-01
00194613017286MSI Precision Specialty InstrumentsE53782025-08-01
00194613018993MSI Precision Specialty InstrumentsM134002025-08-01
00194613044572MSI Precision Specialty InstrumentsF94982025-08-01
00194613089696MSI Precision Specialty InstrumentsF94952025-08-01
00194613109684MSI Precision Specialty InstrumentsE53702025-08-01
00194613110772MSI Precision Specialty InstrumentsE53762025-08-01
00194613003845MSI Precision Specialty Instruments5-14452024-08-15
00194613044800MSI Precision Specialty Instruments17-13502024-08-15
00194613045173MSI Precision Specialty Instruments17-13302024-08-15
00194613045685MSI Precision Specialty Instruments2380182024-08-15
00194613046354MSI Precision Specialty Instruments17-13122024-08-15
00194613055332MSI Precision Specialty Instruments17-13102024-08-15
00194613018382MSI Precision Specialty Instruments52-20632025-08-01
00194613018504MSI Precision Specialty Instruments52-22612025-08-01
00194613018771MSI Precision Specialty Instruments51-23012025-08-01
00194613018788MSI Precision Specialty Instruments51-25012025-08-01
00194613018856MSI Precision Specialty Instruments51-19012025-08-01
00194613020873MSI Precision Specialty Instruments51-20012025-08-01
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975808861300MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861317MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861324MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861331MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861348MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861355MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861362MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861379MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861386MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861303MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861310MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861327MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861334MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861341MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861358MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861365MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861372MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861389MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
10840113298782CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
10840113299765CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
20840113299076CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00814707024043CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
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 DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482041451Symmetry DeschASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054918Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054925Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00854037007170eXact Suture Placement DeviceCypris Medical, Inc.GEJ2024-06-10