FDA.reportPublic FDA data

JEDMED

Primary DI
M6335824880
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
58-2488
Catalog number
58-2488
Device description
WRIGHT FASCIA NEEDLE
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDLNeedle, Suturing, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDLNeedle, Suturing, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6335824880PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428044MillenniumAvalign Technologies, Inc.GDL2026-08-27
04054462906604evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906611evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906628evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906635evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906642evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906666evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906918evonosevonos GmbH & Co. KGGDL2026-08-21
04054462906659evonosevonos GmbH & Co. KGGDL2026-08-18
04054462906673evonosevonos GmbH & Co. KGGDL2026-08-18
00194613031718MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613040130MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613054878MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613084950MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112493MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112509MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112622MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112684MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613113308MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119843MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119850MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119874MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119881MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119898MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119911MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121129MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121136MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00190776401764MillenniumAvalign Technologies, Inc.GDL2025-06-13
00190776397715MillenniumAvalign Technologies, Inc.GDL2025-05-16
00194613106218MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21