AccessGUDID - DEVICE: NES Reprocessed .035 Stryker Catheter (B227RS889011)

GUDID

Device Identifier (DI) Information

Brand Name: NES Reprocessed .035 Stryker Catheter
Version or Model: R-S88901
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R-S88901
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: B227RS889011
Issuing Agency: HIBCC
Commercial Distribution End Date: November 24, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use

Device Description: NES Reprocessed .035 IVUS reprocessed for Stryker (SSS)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
64174	Intravascular ultrasound imaging catheter, reprocessed	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWQ	Reprocessed Intravascular Ultrasound Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181126	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Working Length: 90 Centimeter
Lumen/Inner Diameter: 0.035 Inch

Device Record Status

Public Device Record Key: 7e9cdfe4-4e49-4d99-bcf9-990029234942
Public Version Date: August 26, 2024
Public Version Number: 1
DI Record Publish Date: August 16, 2024