AccessGUDID - DEVICE: Stealth (10850000491301)

GUDID

Device Identifier (DI) Information

Brand Name: Stealth
Version or Model: RAD-SC30-125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-10059-05
Company Name: Cardiovascular Systems, Inc.

Primary DI Number: 10850000491301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024954518 *Terms of Use

Device Description: STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft

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?
44307	Mechanical atherectomy system catheter, peripheral	A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Intro Sheath 5 Fr
Device Size Text, specify: Max OD 0.063 inches
Device Size Text, specify: Crown Type Solid
Device Size Text, specify: High Speed 120 krpm
Device Size Text, specify: Medium Speed 90 krpm
Device Size Text, specify: Low Speed 60 krpm
Device Size Text, specify: Guidewire 0.014 inches
Device Size Text, specify: Shaft Length 200 cm
Device Size Text, specify: Nose Length 10 mm
Device Size Text, specify: Crown Diameter 1.5 mm

Device Record Status

Public Device Record Key: cc8d64bc-b137-4eb6-9ce7-810db8e81dbe
Public Version Date: July 17, 2025
Public Version Number: 2
DI Record Publish Date: September 10, 2019

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

Customer Contact

[?]

Phone: 877-274-0360
Email: customerservice@csi360.com

Phone: 651-259-1600
Email: customerservice@csi360.com

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