AccessGUDID - DEVICE: AuST Steerable Sheath (00810024672004)

GUDID

Device Identifier (DI) Information

Brand Name: AuST Steerable Sheath
Version or Model: 0-132H-H5074SAN0-SNSP0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CENTERPOINT SYSTEMS LLC

Primary DI Number: 00810024672004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117126091 *Terms of Use

Device Description: The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

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?
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
DYB	Introducer, Catheter
DRA	Catheter, Steerable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K251051	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
Device Size Text, specify: Catheter Inner Diameter, French Size = 13.2F
Device Size Text, specify: Outer Diameter, French Size = 17F
Catheter Working Length: 74 Centimeter
Device Size Text, specify: Distal Deflection Diameter, Bidirectional = 50mm

Device Record Status

Public Device Record Key: 8b8844f9-671b-446b-961b-35f8e54092d4
Public Version Date: February 06, 2026
Public Version Number: 1
DI Record Publish Date: January 29, 2026