CATH C315S402 Medical Device Identification

GUDID 00763000160210

CATH C315S402

MEDTRONIC, INC.

Vascular guide-catheter, single-use

Primary Device ID	00763000160210
NIH Device Record Key	b8d74193-b4c3-4c46-a1bf-f8541fad377f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	C315S402
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
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
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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000160210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192712

FDA Product Code

DQY	Catheter, percutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-11-06
Device Publish Date	2020-10-29

Devices Manufactured by MEDTRONIC, INC.

00199150071623 - NA	2026-03-16 CUSTOM PACK BB11X36R2 EVL SUPPORT
20199150071917 - NA	2026-03-16 CUSTOM PACK BB8S03R4 10PK EVL ACCESS
00199150071920 - NA	2026-03-16 CUSTOM PACK BB9G55R9 HLO TVA FU
00199150071937 - NA	2026-03-16 CUSTOM PACK BB10P43R7 TRIDENT A
00199150071944 - NA	2026-03-16 CUSTOM PACK BB12R46R1 EVL TABLE
20199150072020 - NA	2026-03-16 CUSTOM PACK BB12T66R 10PK AVL HALI
00199150072033 - NA	2026-03-16 CUSTOM PACK BB11W59R9 EVL P-MAG
00199150072040 - NA	2026-03-16 CUSTOM PACK BB9E90R12 EVL 3/8 SPRT