N/A

GUDID 00847536003835

RMCS-2.75US DETACHMENT CABLE SET

Reverse Medical Corporation

Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use

Primary Device ID	00847536003835
NIH Device Record Key	4ab20d49-a572-4c97-9322-962ed545ca4a
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	RMCS-2.75US
Company DUNS	963324913
Company Name	Reverse Medical Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry, secure place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536003835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133282

FDA Product Code

KRD	Device, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

[00847536003835]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-08-08
Device Publish Date	2015-09-15

On-Brand Devices [N/A]

00847536003873	ED2-RM-US DETACHMENT SYSTEM
00847536003835	RMCS-2.75US DETACHMENT CABLE SET