Evonos

Austin Dissection Knife 90 Degree Blade Angle 1.02 MM Blade Length Stainless Steel Ebony

Registry build 21.09.26
11manufacturers in China registered for this device type
291catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRC
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Elite Medtek(Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Jiangsu Yongle Medical Technology Co., Ltd. Taixing Jiangsu Manufacturer 4

Record

Regulatory record for Evonos
Listed by Gyrus Acmi, Inc., United States
FDA product code LRC
Device type Instrument, Ent Manual Surgical
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-09-10
Record revised 2024-09-02 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Distribution end date 2025-03-31

Catalogue Numbers

Catalogue numbers for Evonos
Catalogue number Size Status
130362 In distribution
230077 In distribution
130581 In distribution
130180 In distribution
130262 In distribution
130363 In distribution
130094 In distribution
130351 In distribution
130022 In distribution
130364 In distribution
131014 In distribution
130205 In distribution
230051 In distribution
130244 In distribution
130253 In distribution
130305 In distribution
130330 In distribution
130308 In distribution
130167 In distribution
131206 In distribution
131222 In distribution
130432 In distribution
130208 In distribution
130311 In distribution
70130932 In distribution
130172 In distribution
130267 In distribution
130266 In distribution
130254 In distribution
131230 In distribution
130567 In distribution
130092 In distribution
130036 In distribution
130017 In distribution
130108 In distribution
131219 In distribution
130384 In distribution
270202 In distribution
130857 In distribution
131233 In distribution
130306 In distribution
130175 In distribution
130166 In distribution
70133000 In distribution
130853 In distribution
70133001 In distribution
130174 In distribution
130112 In distribution
130884 In distribution
130317 In distribution
130410 In distribution
130356 In distribution
130164 In distribution
130312 In distribution
230006 In distribution
130169 In distribution
130207 In distribution
131229 In distribution
130024 In distribution
130854 In distribution
130859 In distribution
130549 In distribution
130576 In distribution
130579 In distribution
130575 In distribution
130569 In distribution
130249 In distribution
130163 In distribution
130168 In distribution
130138 In distribution
130570 In distribution
131232 In distribution
130572 In distribution
231008 In distribution
130243 In distribution
130415 In distribution
131234 In distribution
131225 In distribution
131209 In distribution
130392 In distribution
130016-ENT In distribution
134002 In distribution
130179 In distribution
130855 In distribution
130403 In distribution
130165 In distribution
230080 In distribution
130117 In distribution
130309 In distribution
130263 In distribution
130441 In distribution
130882 In distribution
130318 In distribution
130407 In distribution
130095 In distribution
130185 In distribution
131220 In distribution
70235613 In distribution
130390 In distribution
130031 In distribution
131040 In distribution
130447 In distribution
130118 In distribution
130211 In distribution
130409 In distribution
130433 In distribution
230072 In distribution
231076 In distribution
230007 In distribution
230038 In distribution
130176 In distribution
130852 In distribution
130202 In distribution
130111 In distribution
134001 In distribution
130103 In distribution
131044 In distribution
130573 In distribution
130574 In distribution
130404 In distribution
131202 In distribution
130039 In distribution
130360 In distribution
130366 In distribution
130851 In distribution
130435 In distribution
130414 In distribution
131216 In distribution
131201 In distribution
130247 In distribution
130604 In distribution
70235621 In distribution
130290 In distribution
70133005 In distribution
130381 In distribution
130472 In distribution
130203 In distribution
130261 In distribution
130445 In distribution
270213 In distribution
130184 In distribution
130610 In distribution
130102 In distribution
130269 In distribution
70130934 In distribution
130442 In distribution
130178 In distribution
130564 In distribution
131026 In distribution
131080 In distribution
130264 In distribution
130359 In distribution
230073 In distribution
130113 In distribution
130470 In distribution
130331 In distribution
130206 In distribution
131208 In distribution
130250 In distribution
131027 In distribution
131210 In distribution
130023 In distribution
130246 In distribution
230062 In distribution
131012 In distribution
130885 In distribution
130383 In distribution
130248 In distribution
130148 In distribution
130037-ENT In distribution
130886 In distribution
130268 In distribution
130093 In distribution
130182 In distribution
130135 In distribution
130035 In distribution
131013 In distribution
130450 In distribution
130571 In distribution
130034 In distribution
130352 In distribution
131042 In distribution
130858 In distribution
130402 In distribution
130976 In distribution
130137 In distribution
130270 In distribution
130406 In distribution
130021-ENT In distribution
70134009 In distribution
130883 In distribution
130173 In distribution
131211 In distribution
230071 In distribution
130354 In distribution
130444 In distribution
130361 In distribution
131024 In distribution
130830 In distribution
130313 In distribution
131010 In distribution
130186 In distribution
130401 In distribution
130251 In distribution
130170 In distribution
130259 In distribution
131025 In distribution
130357 In distribution
917606 In distribution
130033 In distribution
131015 In distribution
130307 In distribution
130032 In distribution
130358 In distribution
130258 In distribution
130577 In distribution
130204 In distribution
131041 In distribution
130212 In distribution
130041 In distribution
130578 In distribution
230063 In distribution
130104 In distribution
130434 In distribution
130431 In distribution
130436 In distribution
130413 In distribution
70133002 In distribution
130146 In distribution
130106 In distribution
131028 In distribution
130038 In distribution
130566 In distribution
131235 In distribution
130245 In distribution
70235620 In distribution
130040 In distribution
130536 In distribution
131205 In distribution
130408 In distribution
130107 In distribution
130265 In distribution
130019 In distribution
130291 In distribution
231062 In distribution
130171 In distribution
130020 In distribution
130353 In distribution
130252 In distribution
130405 In distribution

Showing 250 of 291 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Instrument, Ent Manual Surgical Karl Storz GmbH & Co. KG 2,062
Fentex Fentex medical GmbH 1,738
Elmed Elmed, Inc. 504
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 441
Millennium Avalign Technologies, Inc. 283
Elmed Incorporated Elmed, Inc. 277
Instrument, Ent Manual Surgical Stryker Leibinger Gmbh & Co. KG 169
Rhinoforce Karl Storz GmbH & Co. KG 112
Surtex Surtex Instruments Ltd 85
Kerrison sphenoid punch Spiggle & Theis Medizintechnik Gmbh 82
Gyrus Acmi Gyrus Acmi, Inc. 78
MSI Precision Specialty Instruments MED Saver, Inc. 63

Showing 12 of 661. All products under Instrument, Ent Manual Surgical

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2013-05-24 Class II Employee error lack of sterility assurance 100 boxes of 6 units 2014-05-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer