FDA.reportPublic FDA data

evonos

Primary DI
04054462955107
Brand
evonos
Company
evonos GmbH & Co. KG
Model
48-000002
Device description
EVOFRAME, SQUARE, STERILE, 14.4CMx14.4CM
Published
2025-06-08
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
04054462955107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462955107040544629551074054462955107

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, single-useA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a single-use device.

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
04054462156238evonosEVO-WT645001EVO-WT6450012026-10-28
04054462156252evonosEVO-WT645010EVO-WT6450102026-10-28
04054462156481evonosWT119400WT1194002026-08-26
04054462156498evonosWT524820WT5248202026-08-26
04054462156504evonosWT415000WT4150002026-08-26
04054462913039evonosWT415100WT4151002026-08-26
04054462913602evonosWT430432WT4304322026-08-25
04054462913619evonosWT430450WT4304502026-08-25
04054462913626evonosWT430452WT4304522026-08-25
04054462913633evonosWT432000WT4320002026-08-25
04054462913732evonosWT438512WT4385122026-08-25
04054462913763evonosWT438714WT4387142026-08-25
04054462913794evonosWT439000WT4390002026-08-25
04054462913824evonosWT439100WT4391002026-08-25
04054462913831evonosWT439200WT4392002026-08-25
04054462913855evonosWT440500WT4405002026-08-25
04054462913893evonosWT441500WT4415002026-08-25
04054462913909evonosWT442000WT4420002026-08-25
04054462913916evonosWT442100WT4421002026-08-25
04054462913923evonosWT442200WT4422002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439811MilleniumAvalign Technologies, Inc.GAD2026-10-28
B382SD907310080Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD9141781200Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD91417912190Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B8039018650ORTHOMEDORTHO-MED, INC.GAD2026-10-27
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437169MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776439781MilleniumAvalign Technologies, Inc.GAD2026-10-26
00190776436957MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437015MillenniumAvalign Technologies, Inc.GAD2026-10-23
00190776437022MillenniumAvalign Technologies, Inc.GAD2026-10-23
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19