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DEVICE DETAILS

NAME OF DEVICEROVAC KARMAN CURETTES
ESTABLISHMENT NAMEPRIMAMEDIK SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB9249623-114992
BRAND NAMEROVAC
MEDICAL DEVICE CATEGORYMD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Karman Curette is a suction tip combined with a scraping surgical instrument with a ring-shaped or fenestrated tip which can be either rigid or malleable, having a sharp or blunt tip. The Rovac curettage tubing is connected to either wall suction or a suction canister, and to a suction tip such as a Karman curette. Body fluids and tissues are removed during surgical applications when suction is applied.
DEVICE INTENDED PURPOSEDKC: The Disposable Karman Curette (DKC) is a suction tip combined with a scraping surgical instrument that has a ring shaped or fenestrated tip. The DKC is indicated to scrape or remove tissue during gynaecological procedures.
VALIDITY DATE OF REGISTRATION13/12/2022 - 12/12/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Karman CuretteDKC3006
2Karman CuretteDKC3007
3Karman CuretteDKC3008
4Karman CuretteDKC3009
5Karman CuretteDKC3010
6Karman CuretteDKC3011
7Karman CuretteDKC3012
8Karman CuretteDKC3206
9Karman CuretteDKC3207
10Karman CuretteDKC3208
11Karman CuretteDKC3209
12Karman CuretteDKC3210
13Karman CuretteDKC3211
14Karman CuretteDKC3212
15Karman CuretteDKC3306
16Karman CuretteDKC3307
17Karman CuretteDKC3308
18Karman CuretteDKC3309
19Karman CuretteDKC3310
20Karman CuretteDKC3311
21Karman CuretteDKC3312
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