AccessGUDID - DEVICE: PROGREAT (04987350738165)

GUDID

Device Identifier (DI) Information

Brand Name: PROGREAT
Version or Model: MC*PC2015ZRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC*PC2015ZRA
Company Name: TERUMO CORPORATION

Primary DI Number: 04987350738165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: PROGREAT Microcatheter System

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?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, intravascular, diagnostic
KRA	Catheter, continuous flush

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.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.67 Millimeter
Length: 150 Centimeter
Lumen/Inner Diameter: 0.49 Millimeter

Device Record Status

Public Device Record Key: af2ea9f4-dc52-429b-b476-a883f435ea8a
Public Version Date: September 14, 2021
Public Version Number: 1
DI Record Publish Date: September 06, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
54987350738160	5	04987350738165		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)283-7866
Email: tmccustomer.admin@terumomedical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES