FDA.reportPublic FDA data

evonos

Primary DI
04054462913237
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT420001
Catalog number
WT420001
Device description
Retractor, acc. to Cottle-Neivert, double-ended, size 10 x 190
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462913237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462913237040544629132374054462913237

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342657915
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054462910793evonosWT335401WT3354012026-08-19
04054462910823evonosWT335404WT3354042026-08-19
04054462910830evonosWT335405WT3354052026-08-19
04054462910847evonosWT335406WT3354062026-08-19
04054462910854evonosWT335409WT3354092026-08-19
04054462910861evonosWT335410WT3354102026-08-19
04054462910878evonosWT335413WT3354132026-08-19
04054462910885evonosWT335414WT3354142026-08-19
04054462910892evonosWT335500WT3355002026-08-19
04054462910908evonosWT335600WT3356002026-08-19
04054462910915evonosWT335800WT3358002026-08-19
04054462910922evonosWT335801WT3358012026-08-19
04054462910939evonosWT335802WT3358022026-08-19
04054462910953evonosWT335901WT3359012026-08-19
04054462910960evonosWT335902WT3359022026-08-19
04054462910991evonosWT336101WT3361012026-08-19
04054462911011evonosWT336202WT3362022026-08-19
04054462911028evonosWT336203WT3362032026-08-19
04054462911035evonosWT336204WT3362042026-08-19
04054462911042evonosWT336300WT3363002026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915835evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915842evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915859evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915873evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915880evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915897evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915927evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915934evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916139evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916146evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916153evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916191evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916207evonosevonos GmbH & Co. KGKAL2026-08-17
04054462916221evonosevonos GmbH & Co. KGKAL2026-08-17