Elmed

Yezerski Small Bone Rongeur, Small, Overall Length: 7.125" (18,1 cm), Jaw Width: 4 mm Jaw, Bite Width: 3 mm Jaw Bite Length: 20 mm

Registry build 21.09.26
11manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTX
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Qingdao Zhixing Medical Instrument Co., Ltd. Qingdao Shandong Manufacturer 6

Record

Regulatory record for Elmed
Listed by Elmed, Inc., United States
FDA product code HTX
Device type Rongeur
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-07-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Elmed
Catalogue number Size Status
STELJ803QRS In distribution
SS8-5MM40PIN In distribution
SC8-2MM40 In distribution
ST3314220 In distribution
SC8-4MM40PIN In distribution
CC11-3MM40 In distribution
EL.J805QRS In distribution
ST1264000452 In distribution
SS8-6MM40PIN In distribution
STELJ801QRS In distribution
SC8-1.5MM40C In distribution
33155-18 In distribution
SS8-2.0MM40PIN In distribution
SC8-5MM40PIN In distribution
ST2347458 In distribution
CC11-5MM40 In distribution
33230-22 In distribution
SS7-4MM40PIN In distribution
SS7-3MM40PIN In distribution
41452-03 In distribution
EL.J801QRS In distribution
EL.J803QRS In distribution
SS8-4MM40PIN In distribution
SC8-5MM40 In distribution
SS7-1.5MM40 In distribution
SS9-2.5MM40 In distribution
SS9-1.5MM40 In distribution
CC11-2MM40 In distribution
23-47458 In distribution
EL.J804QRS In distribution
SS8-1MM40 In distribution
SC8-1MM40 In distribution
CC11-1MM40 In distribution
SS8-2MM40 In distribution
SS8-4MM40 In distribution
SC8-2MM40PIN In distribution
ST3323022 In distribution
23-470490 In distribution
STELJ804QRS In distribution
SS8-1.5MM40 In distribution
EL.J802QRS In distribution
EL.J806QRS In distribution
41422-02 In distribution
SS8-3MM40 In distribution
SS7-2MM40PIN In distribution
24-0801CC-FU In distribution
SC8-3MM40PIN In distribution
SS7-4MM40 In distribution
23-1789-01 In distribution
SS9-2MM40 In distribution
STELJ805QRS In distribution
12-64000452 In distribution
SS9-1MM40 In distribution
SC8-3MM40 In distribution
SC9-3MM40 In distribution
SS7-3MM40 In distribution
ST3315518 In distribution
STELJ802QRS In distribution
SS8-5MM40 In distribution
SC9-4MM40 In distribution
SS8-3MM40PIN In distribution
24-0803CC-FU In distribution
33142-20 In distribution
33142-28 In distribution
CC11-4MM40 In distribution
SS7-2MM40 In distribution
SS8-2.5MM40PIN In distribution
ST23178901 In distribution
24-0802CC-FU In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 2,994
Life Instruments Life Instrument Corp. 1,252
Novo Surgical Novo Surgical, Inc. 1,227
Surgical Direct Surgical Direct, Inc. 1,208
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 712
gSource Gsource, LLC. 509
Novo Surgical Inc. Novo Surgical, Inc. 397
Peak MED Peak Medical Distribution Inc 320
Aesculap Aesculap AG 264
MSI Precision Specialty Instruments MED Saver, Inc. 244
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 239
HNM Medical HNM Stainless, LLC. 186

Showing 12 of 438. All products under Rongeur

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