R-MED, INC.

Address:3465 NAVARRE AVENUE,OREGON,OH,43616,US

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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

Laparoscope, Gynecologic (And Accessories) (HET) (3)

Premarket Exempt

Clear

R-Med, Inc. - B44510152 Catalog Number : 10152

Device Description : 10 mm R-Med Plug is used for retention of pneumoperitoneum during 10 mm trocar d 10 mm R-Med Plug is used for retention of pneumoperitoneum during 10 mm trocar defect closure. To be used with Riza-Ribe or GraNee needle.

Device Class :

Duns Number: 962874897

Premarket Exempt : No

Product Code : HET

Prescription Use : No

Device Count : 1

R-Med, Inc. - B44510154 Catalog Number : 10154

Device Description : 12 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar de 12 mm R-Med Plug is used for retention of pneumoperitoneum during 12mm trocar defect closure. To be used with Riza-Ribe or GraNee needle.

Device Class :

Duns Number: 962874897

Premarket Exempt : No

Product Code : HET

Prescription Use : No

Device Count : 1

R-Med, Inc. - B44510165 Catalog Number : 10165

Device Description : The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Lap The GraNee Needle is as a Grasper and a Needle used during Laparoscopy, Mini-Laparoscopy and Operative Laparoscopy for suture passing and retrieval, trocar port closure and hernia repair.

Device Class :

Duns Number: 962874897

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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