FDA.reportPublic FDA data

evonos

Primary DI
04054462151080
Brand
evonos
Company
evonos GmbH & Co. KG
Model
48-000116
Device description
EVOHOOK, TI DOUBLE-HOOK, BLUNT, STERILEL=23MM, W=10MM, H=8MM, STRING=200MM
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462151080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462151080040544621510804054462151080

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, single-useA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342657915
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054462923465evonos2301932301932026-06-26
04054462915583evonosWT518001WT5180012026-06-25
04054462122974evonos48-0000212025-07-25
04054462150489evonos48-0000352025-07-25
04054462150717evonos48-0000362025-07-25
04054462150724evonos48-0000372025-07-25
04054462150731evonos48-0000382025-07-25
04054462150748evonos48-0000392025-07-25
04054462150755evonos48-0000402025-07-25
04054462150762evonos48-0000412025-07-25
04054462151059evonos48-0000752025-07-25
04054462151066evonos48-0001142025-07-25
04054462151073evonos48-0001152025-07-25
04054462151097evonos48-0001182025-07-25
04054462151103evonos48-0001192025-07-25
04054462151110evonos48-0001202025-07-25
04054462151127evonos48-0001212025-07-25
04054462151134evonos48-0001352025-07-25
04054462151141evonos48-0001362025-07-25
04054462151158evonos48-0001372025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421977MillenniumAvalign Technologies, Inc.GAD2026-07-23
00198506091926ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21