AccessGUDID - DEVICE: R2P SLENGUIDE (04987892046636)

GUDID

Device Identifier (DI) Information

Brand Name: R2P SLENGUIDE
Version or Model: WG-S7ST1L23A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WG-S7ST1L23A
Company Name: TERUMO CORPORATION

Primary DI Number: 04987892046636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: R2P SlenGuide Guiding Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.
Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 2.20 Millimeter
Outer Diameter: 2.37 Millimeter
Length: 120.00 Centimeter

Device Record Status

Public Device Record Key: e12d50a2-cecc-43ff-baff-63ade65a3c1f
Public Version Date: December 22, 2021
Public Version Number: 6
DI Record Publish Date: September 29, 2017