8F Base Camp Sheath System REF 5001

GUDID 00853799007404

8F Base Camp Sheath System

ROUTE 92 MEDICAL

Vascular guide-catheter, single-use
Primary Device ID00853799007404
NIH Device Record Key81097905-dffc-4424-8e9f-2f01d7c37dd6
Commercial Distribution StatusIn Commercial Distribution
Brand Name8F Base Camp Sheath System
Version Model NumberFD 0743
Catalog NumberREF 5001
Company DUNS067429673
Company NameROUTE 92 MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com
Phone650-350-9416
EmailCustomerservice@r92m.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853799007404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-25
Device Publish Date2020-09-17

On-Brand Devices [8F Base Camp Sheath System]

008537990074048F Base Camp Sheath System
008537990074118F Base Camp Sheath System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.