F.R.GALANTAI MANUFACTURING COMPANY LIMITED

Address:11 Bancroft Crescent,Auckland,NZ

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessories, Cleaning Brushes, For Endoscope (MNL) (9)

Premarket Exempt

Yes

Clear

PULL THRU™ Cleaning Brush - 09421028490092 Catalog Number : ZZ2850+180+0+2200

Device Description : Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers

Device Class :

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 180

PULL THRU™ Cleaning Brush - 09421028490221 Catalog Number : ZZSB512+180

Device Description : Port cleaning brush, double head, 5mm and 12mm.

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 180

PULL THRU™ Cleaning Brush - 09421028490320 Catalog Number : ZZ2850+240+0+2200

Device Description : Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 240

PULL THRU™ Cleaning Brush - 09421028490399 Catalog Number : ZZPT2850+60+0+230

Device Description : Channel cleaning brush, channel ID 2.8-5.0mm, length 230mm, 2 x 360 degree wipers

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 60

PULL THRU™ Cleaning Brush - 09421028490634 Catalog Number : ZZ2850+1+CARD+2200

Device Description : 1 x Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers.

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

PULL THRU™ Cleaning Brush - 09421028490788 Catalog Number : ZZ2850+60+0+2200

Device Description : Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 60

PULL THRU™ Cleaning Brush - 09421028491198 Catalog Number : ZZ2850+1+SPUP+2200

Device Description : 1 x Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree w 1 x Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers.1 x Port cleaning brush, double head, 5mm and 12mm.

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

PULL THRU™ Cleaning Brush - 09421028491211 Catalog Number : ZZ2850+1200+0+2200

Device Description : Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1200

PULL THRU™ Cleaning Brush - 09421028493154 Catalog Number : ZZ2850+60+NC+2200

Device Description : 1 x Dispenser cassette.60 x Channel cleaning Brush, channel ID 2.8-5.0mm, length 1 x Dispenser cassette.60 x Channel cleaning Brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers.

Device Class : 1

Duns Number: 591592316

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 60

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