EMMY MEDICAL LLC

Address:18 Hillside Dr,Holliston,MA,01746,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

Catheter, Retention Type, Balloon (EZL) (2) Cystoscope And Accessories, Flexible/Rigid (FAJ) (2)

Premarket Exempt

Clear

Cystosure - 00866403000203 Catalog Number :

Device Description : Cystosure XL, 16 Fr, silicone catheter

Device Class :

Duns Number: 052321836

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Cystosure - 00866403000210 Catalog Number :

Device Description : 16Fr Cystosure Plus, 16Fr, silicone catheter

Device Class :

Duns Number: 052321836

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Cystosure - 00866403000234 Catalog Number :

Device Description : Scope, 70 deg, 2.7 mm, long (270mm)

Device Class : 2

Duns Number: 052321836

Premarket Exempt : No

Product Code : FAJ

Prescription Use : Yes

Device Count : 1

Cystosure - 00866403000265 Catalog Number :

Device Description : Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long

Device Class : 2

Duns Number: 052321836

Premarket Exempt : No

Product Code : FAJ

Prescription Use : Yes

Device Count : 1

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