RANFAC CORP.

Address:30 DOHERTY AVE,Avon,MA,02322,US

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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

Instrument, Biopsy (KNW) (5) Cannula, Injection (FGY) (3) Reamer (HTO) (2)

Premarket Exempt

No Yes

Clear

CER-RMR-8 - 00850023741110 Catalog Number : CER-RMR-8

Device Description : Cervos 8GA ReamersP/N: 74370-01MCustomer #: 12153

Device Class :

Duns Number: 121622872

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

CER-RMR-11 - 00850023741127 Catalog Number :

Device Description : Cervos 11GA ReamersP/N: 74371-01MCustomer #: 12153

Device Class :

Duns Number: 121622872

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MC-RAN-13FA - 00850023741134 Catalog Number : MC-RAN-13FA

Device Description : MC-RAN-13FA, F/G, STERILEP/N 74372-01M

Device Class :

Duns Number: 121622872

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CER-SUB-825 - 00850023741141 Catalog Number : 74375-01M

Device Description : Cervos 8GA Subchondral NeedleP/N: 74375-01MCustomer #: 12153

Device Class :

Duns Number: 121622872

Premarket Exempt : Yes

Product Code : FGY

Prescription Use : Yes

Device Count : 1

CER-ORTHO-M - 00850023741158 Catalog Number : CER-ORTHO-M

Device Description : CER-ORTHO-M, F/G, STERILEP/N 74376-01M

Device Class :

Duns Number: 121622872

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

CER-SUB-825-M - 00850023741189 Catalog Number : CER-SUB-825-M

Device Description : Cervos 8GA Delivery CannulaP/N: 74379-01MCustomer#: 12153

Device Class :

Duns Number: 121622872

Premarket Exempt : Yes

Product Code : FGY

Prescription Use : Yes

Device Count : 1

CER-SUB-1111-OT-BNT - 00850023741196 Catalog Number : CER-SUB-1111-OT-BNT

Device Description : Cervos 11GA X 11" Delivery Cannula, Open Tip, With Blunt StyletP/N: 74383-01MCus Cervos 11GA X 11" Delivery Cannula, Open Tip, With Blunt StyletP/N: 74383-01MCustomer #: 12153

Device Class :

Duns Number: 121622872

Premarket Exempt : Yes

Product Code : FGY

Prescription Use : Yes

Device Count : 1

MC-RAN-13FA - 00850023741202 Catalog Number : MC-RAN-13FA

Device Description : MC-RAN-13FA, F/G, Sterile P/N 74384-01M

Device Class :

Duns Number: 121622872

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

RAN-1115H5T-BNT - 00850023741219 Catalog Number : RAN-1115H5T-BNT

Device Description : RAN-1115H5T-BNTPN 74392-15M

Device Class :

Duns Number: 121622872

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Cervos Flex Bone Marrow Aspiration Needle - 00850023741226 Catalog Number : CER-FLEX

Device Description : Cervos Flex Bone Marrow Aspiration Needle, Sterile, F/GP/N 74390-01M

Device Class :

Duns Number: 121622872

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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