AccessGUDID - DEVICE: Acculink™ (08717648076213)

GUDID

Device Identifier (DI) Information

Brand Name: Acculink™
Version or Model: 1011338-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1011338-20
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648076213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: RX ACCULINK™ Carotid Stent System 6.0 mm x 20 mm x 132 cm Rapid-Exchange

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
45851	Bare-metal carotid artery stent	A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIM	STENT, CAROTID

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: Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b54ed80f-56eb-4688-b6ef-905539b02054
Public Version Date: April 25, 2025
Public Version Number: 5
DI Record Publish Date: November 21, 2014

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: +1(800)227-9902
Email: john3103@gmail.com

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