Who else makes this device?

Name: Acecide-C
Brand: Acecide-C

General Hospital › MiscellaneousSterilant, Medical Devices

Acecide-C

2 catalogue numbers from Acecide-C (PLAC01), listed by Best Sanitizers, Inc., United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MED
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Acecide-C
Listed by	Best Sanitizers, Inc., United States
FDA product code	MED
Device type	Sterilant, Medical Devices
Device class	Class 2
Regulation	21 CFR 880.6885
Establishment	Manufacturer
510(k)	K091210
Record published	2024-06-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 32 to 77 °F

Catalogue Numbers

Catalogue numbers for Acecide-C
Catalogue number	Size	Status
Acecide-C (PLAC01)		In distribution
Acecide-C (PLAC04)		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sterilant, Medical Devices	Steris Corporation	149
Formed Irrigating Cystotomes	Sterimedix Ltd.	37
Hydrodissection Cannulae	Sterimedix Ltd.	29
Sterilant, Medical Devices	Corporation Steris Canada	29
Anterior Chamber Maintenance Cannulae	Sterimedix Ltd.	17
Anaesthetic Needles	Sterimedix Ltd.	14
Formed Capsularhexis Cystotomes	Sterimedix Ltd.	8
Refractive Cannulae	Sterimedix Ltd.	8
enspire	Corporation Steris Canada	8
Cidex™	Advanced Sterilization Products Services Inc.	8
Bimanual Cannulae and Hand Pieces	Sterimedix Ltd.	7
Bimanual I/A Systems	Sterimedix Ltd.	7

Showing 12 of 96. All products under Sterilant, Medical Devices

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K091210	2010-02-05
K041984	2005-05-11

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Acecide-C
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Best Sanitizers, Inc.	510(k) number	2016-08-02	Class II	Nonconforming Material/Component	Certain lots of the acid solution in Acecide-C are degrading faster than normal.	3,023 cases USA; 666 cases shipped to Canada (OTC drug there	2017-08-18

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.