Who else makes this device?

Name: Codman Certas®
Brand: Codman Certas®

Codman Certas® · Device, Monitoring, Intracranial Pressure → Neurology

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (3), Shanghai (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 GWM
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33

Record

Regulatory record for Codman Certas®
Listed by	Integra LifeSciences Production Corporation, United States
FDA product code	GWM
Device type	Device, Monitoring, Intracranial Pressure
Device class	Class 2
Regulation	21 CFR 882.1620
Establishment	Contract manufacturer, Specification developer, Manufacturer
510(k)	K183406
Record published	2020-02-28
Record revised	2022-06-10 (version 5)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	lot or batch number, serial number
Storage	Special storage condition: Keep Dry; Handling Temperature in C (Low) -30; Handling Temperature in F (Low) -22; Storage Temperature in F (Low) -22; Handling environment temperature up to 140 °F; Handling environment temperature up to 60 °C; Storage environment temperature -30 to 60 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal
Distribution end date	2021-06-07

Catalogue Numbers

Catalogue numbers for Codman Certas®
Catalogue number	Size	Status
826820		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Licox®	GMS, Gesellschaft für medizinische Sondentechnik mbH	38
Sophysa	Sophysa	32
Becker®	Medtronic PS Medical	31
Codman	Cerenovus, Inc.	29
Device, Monitoring, Intracranial Pressure	Medtronic PS Medical	28
Exacta™	Medtronic PS Medical	28
Braincare	Braincare Desenvolvimento E Inovacao Tecnologica SA	24
Camino®	Integra Lifesciences (Ireland) Limited	20
Codman®	Integra LifeSciences Production Corporation	19
Integra®	Integra Lifesciences (Ireland) Limited	17
Aura	Branchpoint & Aura Development LLC	17
Natus	Natus Medical Incorporated	15

Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232890	2024-02-04
K210993	2021-04-30

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 Codman Certas®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Integra Lifesciences Corporation	510(k) number	2019-09-12	Class II	Under Investigation by firm	There is a potential for a progressive decline in observed ICP readings of the monitor during use.	189

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.

Codman Certas®