FDA.reportPublic FDA data

FENTEX

Primary DI
04250407731786
Brand
FENTEX
Company
FENTEX medical GmbH
Model
378200FX
Catalog number
378200FX
Device description
Ligature Needle by Deschamps curved to left 20 cm
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407731786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407731786042504077317864250407731786

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
+4974679496212s.renner@fentexmedical.com

Regulatory Flags#

DUNS number
507221724
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
04250407736507FENTEX441918FX441918FX2022-12-12
04250407736514FENTEX441920FX441920FX2022-12-12
04250407736538FENTEX442014FX442014FX2022-12-12
04250407736545FENTEX442018FX442018FX2022-12-12
04250407736552FENTEX442020FX442020FX2022-12-12
04250407736576FENTEX442114FX442114FX2022-12-12
04250407736590FENTEX442118FX442118FX2022-12-12
04250407736606FENTEX442120FX442120FX2022-12-12
04250407736637FENTEX442214FX442214FX2022-12-12
04250407736644FENTEX442218FX442218FX2022-12-12
04250407736651FENTEX442220FX442220FX2022-12-12
04250407736675FENTEX442314FX442314FX2022-12-12
04250407736682FENTEX442318FX442318FX2022-12-12
04250407736699FENTEX442320FX442320FX2022-12-12
04250407736712FENTEX442414FX442414FX2022-12-12
04250407736729FENTEX442418FX442418FX2022-12-12
04250407736736FENTEX442420FX442420FX2022-12-12
04250407736750FENTEX442514FX442514FX2022-12-12
04250407736767FENTEX442518FX442518FX2022-12-12
04250407736774FENTEX442520FX442520FX2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18