070 Access System REF 1004

GUDID 00853799007442

Vascular guide-catheter, single-use

Primary Device ID	00853799007442
NIH Device Record Key	f23c4e3d-e2fa-4cfe-b827-1afc265cefd6
Commercial Distribution Status	In Commercial Distribution
Brand Name	070 Access System
Version Model Number	Gen 1
Catalog Number	REF 1004
Company DUNS	067429673
Company Name	ROUTE 92 MEDICAL
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00853799007442 [Primary]

QJP	Catheter, Percutaneous, Neurovasculature

Steralize Prior To Use	false
Device Is Sterile	true

00853799007978 - Tenzing 7 Delivery Catheter, Single Pack	2025-08-05 Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541)
00853799007985 - Tenzing 7 Delivery Catheter, 2-pack	2025-08-05 Tenzing 7 Delivery Catheter, 2-pack; Contains 2x of Tenzing 7 Delivery Catheter (00853799007541)
00853799007701 - 8F Base Camp system 2.0 80cm	2024-10-22 8F Base Camp system 2.0 80cm
00853799007718 - 8F Base Camp system 2.0 80cm	2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701)
00853799007725 - 8F Base Camp system 2.0 90cm	2024-10-22 8F Base Camp system 2.0 90cm
00853799007732 - 8F Base Camp system 2.0 90cm	2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725)
00853799007749 - FreeClimb 88 catheter, 125cm	2024-07-09 FreeClimb 88 catheter, 125cm
00853799007756 - FreeClimb 88 catheter, 132cm	2024-07-09 FreeClimb 88 catheter, 132cm