Integra® Miltex®

Integra® Miltex® Seldin Periosteal Elevator 23, Double-Ended, 12.5mm and 10.5mm Wide

Registry build 21.09.26
6manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EMJ
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Integra® Miltex®
Listed by Integra LifeSciences Production Corporation, United States
FDA product code EMJ
Device type Elevator, Surgical, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-10-23
Record revised 2023-05-02 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Sizes Width 2 to 12.5 mm; length 6 in
Distribution end date 2023-12-04

Catalogue Numbers

Catalogue numbers for Integra® Miltex®
Catalogue number Size Status
55827 In distribution
DELH2-3 In distribution
DELLUXC4 4-7/8″ In distribution
DEL1SPD In distribution
DEL3SPD In distribution
55826 In distribution
DEL45 5-7/8″ In distribution
DELW2 In distribution
DEL7X 5-7/8″ In distribution
DEL80 In distribution
DEL26 5-7/8″ In distribution
DELM9 In distribution
DELOHL In distribution
DEL44 5-7/8″ In distribution
DELH1 In distribution
DEL25 5-7/8″ In distribution
DEL34 In distribution
DEL302HF In distribution
DELS23 Width 10.5 mm In distribution
DELLUXS2 In distribution
DELLUXS4 4-7/8″ In distribution
DEL79 In distribution
DELH2 In distribution
DEL3 In distribution
DELB4 In distribution
DEL6X 5-7/8″ In distribution
DEL4R Length 6 in In distribution
DELB3 In distribution
DEL8 In distribution
DEL77R In distribution
DEL303 In distribution
DELB5 In distribution
PM-2232 In distribution
DELLUXS5 In distribution
DEL78 In distribution
DEL4 In distribution
DELPR3 In distribution
DEL46 In distribution
DELA In distribution
DELLUXS3 In distribution
DELLUXC5 4-7/8″ In distribution
DEL5 In distribution
DEL1R 6-1/4″ In distribution
DEL303HF In distribution
DEL34S 6-1/4″ In distribution
DEL301 In distribution
DELB2 In distribution
DEL81 In distribution
DEL4L Length 6 in In distribution
DEL1314 In distribution
DEL2SPD In distribution
DEL1L 6-1/4″ In distribution
DEL302 In distribution
DELB1 In distribution
DELLUXC3 Width 3 mm In distribution
DEL4SPD In distribution
DELLUXC2 Width 2 mm In distribution
DELH3 In distribution
TK24G Withdrawn
DELLUXKIT Withdrawn
TKGF14 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 465
Nordent Manufacturing Inc Nordent Manufacturing Inc 264
Power Dental USA Power Dental U.S.A. Inc. 247
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 233
Elevator KLS-Martin L.P. 231
Kohdent Kohler Medizintechnik GmbH 206
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 153
Stoma® Storz AM Mark Gmbh 150
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121

Showing 12 of 743. All products under Elevator, Surgical, Dental

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