Bausch + Lomb

Duckbill Elevator Double Ended

Registry build 21.09.26
2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code KTG
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Bausch + Lomb
Listed by Bausch & Lomb Incorporated, United States
FDA product code KTG
Device type Knife, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2026-02-04

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bausch + Lomb
Catalogue number Size Status
SP7-100217 In distribution
N1685 S19 In distribution
N1685 S15 In distribution
SP7-69197 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Boss Instruments Boss Instruments, Ltd. 91
Ambler Surgical Ambler Surgical, LLC 87
Aesculap Aesculap AG 48
Pilling Teleflex Medical LLC 47
Millennium Avalign Technologies, Inc. 41
Novo Surgical Inc. Novo Surgical, Inc. 38
MSI Precision Specialty Instruments MED Saver, Inc. 31
Avalign Avalign Technologies, Inc. 30
HNM Medical HNM Stainless, LLC. 27
V. Mueller Steris Corporation 25
Integra® Jarit® Integra LifeSciences Production Corporation 25
Rosen round knife Spiggle & Theis Medizintechnik Gmbh 22

Showing 12 of 83. All products under Knife, Ent

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