AccessGUDID - DEVICE: R-100 (00184360000327)

GUDID

Device Identifier (DI) Information

Brand Name: R-100
Version or Model: 804547001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 804547001
Company Name: VOLCANO CORPORATION

Primary DI Number: 00184360000327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135179237 *Terms of Use

Device Description: R-100 Pullback Device

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:	No
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?
47853	Intravascular ultrasound imaging catheter extractor, reusable	A non-sterile, battery-powered, electronic device intended to slowly retract (pull back) an intravascular ultrasound imaging catheter from a coronary or peripheral artery at a controlled rate using a motor combined with an extraction mechanism. This device is used in the catheterization laboratory during intravascular assessment, e.g., for the reconstruction of a two dimensional, sagittal ultrasonic diagnostic image as the catheter is slowly extracted. Pullback lengths are around 13 cm. This device is not sterilizable and must therefore be enclosed in a sterile barrier (a bag or pouch). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962293	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 31b086f6-4147-446f-8c29-8627d17d0ff4
Public Version Date: July 28, 2023
Public Version Number: 5
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES