Cole Instruments Inc

Address:1070 Powers Pl,Alpharetta,GA,30009,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

Battery, Replacement, Rechargeable (MOQ) (2) Hemostat (HRQ) (1) Motor, Surgical Instrument, Ac-Powered (GEY) (1) Sieves, Tissue (IDX) (1)

Premarket Exempt

Yes

Clear

Graft Cleaning Bowl - 00810072350954 Catalog Number : 630.000

Device Description : Graft cleaning bowl used in the cleaning of follicles removed from the donor are Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient area.

Device Class : 1

Duns Number: 078573265

Premarket Exempt : Yes

Product Code : IDX

Prescription Use : No

Device Count : 1

Powered Cole Isolation Device - 00810072350961 Catalog Number : 900.000

Device Description : Powered Cole Isolation Device.Sterilize handpiece nosecone before first use and Powered Cole Isolation Device.Sterilize handpiece nosecone before first use and before each use.

Device Class : 1

Duns Number: 078573265

Premarket Exempt : Yes

Product Code : GEY

Prescription Use : No

Device Count : 1

mini Powered Cole Isolation Device - 00810072351005 Catalog Number : 910.000

Device Description : mini Powered Cole Isolation Device (mPCID).Sterilize handpiece before first use mini Powered Cole Isolation Device (mPCID).Sterilize handpiece before first use and before each use.

Device Class : 1

Duns Number: 078573265

Premarket Exempt : Yes

Product Code : MOQ

Prescription Use : No

Device Count : 1

Vortex - 00810072351074 Catalog Number : 920.000

Device Description : Vortex.Sterilize handpiece nosecone before first use and before each use.

Device Class : 1

Duns Number: 078573265

Premarket Exempt : Yes

Product Code : MOQ

Prescription Use : No

Device Count : 1

ATOE-Stainless Steel - 00810072351142 Catalog Number : 380.000

Device Description : Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after being punches.

Device Class : 1

Duns Number: 078573265

Premarket Exempt : Yes

Product Code : HRQ

Prescription Use : No

Device Count : 1

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