Who else makes this device?

Name: Millennium
Brand: Millennium

Millennium · Forceps, Ent → Ear Nose & Throat

5manufacturers in China registered for this device type

192catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KAE
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
Tonglu Wanhe Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	24
Tonglu Youshi Medical Instrument Co., Ltd.	Tonglu	Zhejiang	Manufacturer	10

Record

Regulatory record for Millennium
Listed by	Avalign Technologies, Inc., United States
FDA product code	KAE
Device type	Forceps, Ent
Device class	Class 1
Regulation	21 CFR 874.4420
Establishment	Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2023-09-28
Record revised	2023-07-06 (version 2)

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

Catalogue Numbers

Catalogue numbers for Millennium
Catalogue number	Size	Status
16-230578		In distribution
85-22011780		In distribution
2-170586		In distribution
85-22007268		In distribution
31-3721028		In distribution
12-534005		In distribution
15-8681A		In distribution
2-0551		In distribution
2-2997		In distribution
85-23087844		In distribution
13-506470		In distribution
85-20082148		In distribution
1-151426		In distribution
2-170585		In distribution
15-8593H		In distribution
2-3070		In distribution
15-653002		In distribution
85-760P21139		In distribution
2-6500F		In distribution
2-6130		In distribution
0-36696		In distribution
2-5630		In distribution
2-8504		In distribution
72-422068		In distribution
1-19350		In distribution
13-506462		In distribution
17-010247		In distribution
13-505148		In distribution
2-2984		In distribution
2-2974		In distribution
2-2990		In distribution
2-2995		In distribution
2-2985		In distribution
1-405125		In distribution
2-0241A		In distribution
13-506471		In distribution
2-7055		In distribution
16-230592		In distribution
1-MA244R		In distribution
2-7012		In distribution
85-77038990		In distribution
9-53785026		In distribution
85-23087764		In distribution
2-0241		In distribution
2-5345		In distribution
1-2170560		In distribution
1-SP00229		In distribution
1-743075D		In distribution
2-8624		In distribution
16-230726		In distribution
16-76510600		In distribution
2-2988		In distribution
2-3016		In distribution
2-3000		In distribution
0-39074		In distribution
72-422055		In distribution
15-651220		In distribution
17-010248		In distribution
2-7135		In distribution
13-505116		In distribution
2-8546		In distribution
2-2991S		In distribution
16-651253		In distribution
2-6522		In distribution
2-0246		In distribution
1-21630		In distribution
2-0965		In distribution
1-20522		In distribution
16-131041		In distribution
2-2941		In distribution
1-440161		In distribution
14-880677		In distribution
85-20083149		In distribution
15-650212		In distribution
16-130330		In distribution
2-2991		In distribution
2-0244		In distribution
13-505102		In distribution
11-OK245R		In distribution
85-20082833		In distribution
85-192100B		In distribution
17-025325		In distribution
2-2897		In distribution
15-456801B		In distribution
2-0902		In distribution
2-3076		In distribution
2-5620		In distribution
1-450210C		In distribution
2-0249R		In distribution
16-76510601		In distribution
1-30200		In distribution
17-010247INS		In distribution
2-8622		In distribution
1-385125		In distribution
17-010248INS		In distribution
1-385100		In distribution
9-53785025		In distribution
16-230868		In distribution
1-380153		In distribution
1-743075		In distribution
9-22350		In distribution
13-506950		In distribution
2-2992CT		In distribution
2-0958		In distribution
2-8620		In distribution
2-6502		In distribution
72-1230114		In distribution
17-025328		In distribution
2-2967		In distribution
15-625349B		In distribution
2-0950		In distribution
2-29932		In distribution
15-456000		In distribution
72-361202		In distribution
5-22550INS		In distribution
15-651250R		In distribution
1-883R12		In distribution
13-505400		In distribution
2-2983		In distribution
2-X0240		In distribution
2-7010		In distribution
5-22550		In distribution
1-8280		In distribution
2-8626		In distribution
2-169224		In distribution
2-2951		In distribution
13-505106		In distribution
15-651020		In distribution
2-5346		In distribution
1-450205		In distribution
2-2898		In distribution
1-MA245R		In distribution
2-170561		In distribution
2-2900		In distribution
1-506470		In distribution
2-6527		In distribution
15-652024		In distribution
15-650217		In distribution
16-230727		In distribution
15-651250		In distribution
2-2990CT		In distribution
2-5485		In distribution
15-651250L		In distribution
2-5345G		In distribution
1-AU12880		In distribution
2-2856		In distribution
2-29931		In distribution
15-653000		In distribution
16-131209		In distribution
13-506461		In distribution
72-5118319E		In distribution
15-451501B		In distribution
2-2990S		In distribution
85-22011785		In distribution
85-22008542		In distribution
15-653003		In distribution
85-67035712		In distribution
1-380156		In distribution
2-6503F		In distribution
17-025326		In distribution
2-6501F		In distribution
2-6502F		In distribution
13-505112		In distribution
1-01693DL		In distribution
1-MA248R		In distribution
2-0249		In distribution
2-170560		In distribution
1-385130		In distribution
31-3712312		In distribution
2-3074		In distribution
1-OK245R9		In distribution
1-19417		In distribution
2-2991CT		In distribution
2-2980		In distribution
2-2989S		In distribution
2-6504F		In distribution
1-20510		In distribution
85-22011515		In distribution
1-3721041		In distribution
1-530		In distribution
1-883R8		In distribution
16-230577		In distribution
2-7122		In distribution
16-651252		In distribution
15-651251		In distribution
17-025327		In distribution
13-506460		In distribution
1-24640		In distribution
15-8660N		In distribution
13-506455		In distribution
15-8591T		In distribution
1-506472		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ambler Surgical	Ambler Surgical, LLC	400
RZ Medizintechnik GmbH	RZ Medizintechnik Gmbh	308
Boss Instruments	Boss Instruments, Ltd.	278
Pilling	Teleflex Medical LLC	252
Medicon	Medicon eG. Chirurgiemechaniker-Genossenschaft	234
Aesculap	Aesculap AG	229
V. Mueller	Steris Corporation	210
BR Surgical, LLC	BR Surgical LLC	195
Integra®	Integra LifeSciences Production Corporation	191
MicroFrance®	Integra Microfrance SAS	183
Novo Surgical Inc.	Novo Surgical, Inc.	180
Integra® Jarit®	Integra LifeSciences Production Corporation	177

Showing 12 of 318. All products under Forceps, 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.

Millennium

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies