Primed Instruments Inc

Address:1080 TRISTAR DR., UNIT 11, 13 & 14,MISSISSAUGA Ontario,CA

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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

Forceps, Biopsy, Non-Electric (FCL) (7) Accessories, Cleaning Brushes, For Endoscope (MNL) (3)

Premarket Exempt

Yes

Clear

CROC Series Endoscopic Device - 40666416140129 Catalog Number : H928S

Device Description : High capacity single-use biopsy forceps with serrated jaws, needle and ezSlide® High capacity single-use biopsy forceps with serrated jaws, needle and ezSlide® sheath. HIBC/UPN: M453H928S3

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 160

CROC Series Endoscopic Device - 40666416140136 Catalog Number : RC924

Device Description : Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® sheath. HIBC/UPN: M453RC9244

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 80

CROC Multiple Sample Single-Use Biopsy Forceps - 40666416140174 Catalog Number : MC624R

Device Description : Single-Use Multiple Sample Biopsy Forceps and ezSlide® sheath. HIBC/UPN: M453MC624R4

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 80

CROC Multiple Sample Single-Use Biopsy Forceps - 40666416140198 Catalog Number : MC924R

Device Description : Single-Use Multiple Sample Biopsy Forceps and ezSlide® sheath. HIBC/UPN: M453MC924R4

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 80

CROC Multiple Sample Single-Use Biopsy Forceps - 40666416140211 Catalog Number : MC624A

Device Description : Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath. HIBC/UPN: M453MC624A4

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 80

CROC Multiple Sample Single-Use Biopsy Forceps - 40666416140235 Catalog Number : MC924A

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 80

CROC Multiple Sample Single-Use Biopsy Forceps - 40666416140242 Catalog Number : MC924A

Device Class :

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 160

8000 Series Reusable Channel Cleaning Brush - M45381070 Catalog Number : 8107

Device Description : Reusable Tapered Cleaning Brush. HIBC/UPN: M45381070

Device Class : 1

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

8000 Series Reusable Channel Cleaning Brush - M45381150 Catalog Number : 8115

Device Description : Reusable Tapered Cleaning Brush. HIBC/UPN: M45381150

Device Class : 1

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

8000 Series Reusable Channel Cleaning Brush - M45381600 Catalog Number : 8160

Device Description : Reusable Tapered Cleaning Brush. HIBC/UPN: M45381600

Device Class : 1

Duns Number: 254491293

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

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