Coopersurgical, Inc.

Address:95 CORPORATE DRIVE,Trumbull,CT,06611,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

Stapler, Surgical (GAG) (2) Staple, Implantable (GDW) (2) Device, Thermal Ablation, Endometrial (MNB) (1) Electrocautery, Gynecologic (And Accessories) (HGI) (1) Pessary, Vaginal (HHW) (1) Set, Anesthesia, Paracervical (HEE) (1) Speculum, Vaginal, Nonmetal (HIB) (1) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (1) Unit, Cryosurgical, Accessories (GEH) (1) Colposcope (And Colpomicroscope) (HEX) (1)

Premarket Exempt

No Yes

Clear

INSORB - 00867516000104 Catalog Number : REF2030

Device Description : INSORB Subcuticular Skin Stapler REF2030 (each)

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

INSORB - 00867516000111 Catalog Number : REF1008

Device Description : INSORB Subcuticular Skin Stapler REF1008 (each)

Device Class :

Duns Number: 801895244

Premarket Exempt : No

Product Code : GAG, GDW

Prescription Use : Yes

Device Count : 1

Her Option - 00888937000016 Catalog Number :

Device Description : Her Option Console

Device Class : 3

Duns Number: 801895244

Premarket Exempt : No

Product Code : MNB

Prescription Use : Yes

Device Count : 1

LEEP REDIKIT - 00888937000030 Catalog Number :

Device Description : LOOP Electrosurgical Excision Procedure (Contains Lidocaine with Epinephrine)

Device Class :

Duns Number: 801895244

Premarket Exempt : No

Product Code : HEE

Prescription Use : Yes

Device Count : 1

QKit Procedure Tray - 00888937000047 Catalog Number :

Device Description : For LOOP Electrosurgical Excision Procedure - contains Lidocaine with Epinephrine

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Smoke Evacuator Tubing - 00888937000054 Catalog Number :

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

Milex - 00888937000061 Catalog Number :

Device Description : Incontinence Ring Flexible Pessary #0 1 3/4" (44mm)

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : HHW

Prescription Use : Yes

Device Count : 1

Prima Series® Vaginal Speculum - 00888937000078 Catalog Number :

Device Description : Prima Series® Vaginal Speculum • Medium

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : HIB

Prescription Use : Yes

Device Count : 1

LEISEGANG - 00888937000085 Catalog Number :

Device Description : OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo Swing Scope with Canon dSLR Kit

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : HEX

Prescription Use : Yes

Device Count : 1

Leisegang Cryotip for LM-900 - 00888937000108 Catalog Number :

Device Description : LT-2514 Jumbo Exo/Endocervical Cryotip 25mm x 17mm

Device Class : 2

Duns Number: 801895244

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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