HISTOLOGICS, LLC

Address:4095 E La Palma Ave Ste N,Anaheim,CA,92807,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

Curette, Surgical, General Use (FZS) (3) Brush, Biopsy, General & Plastic Surgery (GEE) (2) Curette, Uterine (HCY) (2) Forceps, Biopsy, Gynecological (HFB) (2)

Premarket Exempt

No Yes

Clear

SpiraBrush CX - 00860275000309 Catalog Number : SBX-9000

Device Description : SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.

Device Class :

Duns Number: 023001257

Premarket Exempt : No

Product Code : HFB

Prescription Use : Yes

Device Count : 1

SoftBiopsy - 00860275000316 Catalog Number : SFT-1000

Device Description : Gynecological biopsy device for tissue collection, storage, and transport.

Device Class : 1

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : HFB, GEE

Prescription Use : Yes

Device Count : 1

Soft-ECC - 00860275000323 Catalog Number : SFT-2000

Device Description : Endocervical curette system for tissue collection, storage, and transport.

Device Class : 1

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : HCY

Prescription Use : Yes

Device Count : 1

Soft-ECC-S - 00860275000330 Catalog Number : SFT-2100

Device Description : Endocervical curette system (small size) for tissue collection, storage, and transport.

Device Class : 1

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : HCY

Prescription Use : Yes

Device Count : 1

Soft K-Bride - 00860275000347 Catalog Number : SFT-4000

Device Description : Wound debridement and tissue sampling device, trumpet shaped for body surfaces.

Device Class : 1

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : FZS

Prescription Use : Yes

Device Count : 1

Soft K-Rette - 00860275000354 Catalog Number : SFT-4500

Device Description : Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.

Device Class : 1

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : FZS

Prescription Use : Yes

Device Count : 1

Soft K-Cot(R) - 00860275000361 Catalog Number :

Device Description : The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.

Device Class :

Duns Number: 023001257

Premarket Exempt : Yes

Product Code : FZS, GEE

Prescription Use : No

Device Count : 1

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