AccessGUDID - DEVICE: Neuroform Atlas (07613252656098)

GUDID

Device Identifier (DI) Information

Brand Name: Neuroform Atlas
Version or Model: M003STAS45210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STAS4521
Company Name: Stryker Corporation

Primary DI Number: 07613252656098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042405446 *Terms of Use

Device Description: WITH TIP Stent System

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?
46352	Bare-metal intracranial vascular stent	A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NJE	intracranial neurovascular stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H020002	046
H020002	051
H020002	052
H020002	053

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 cool, dry, dark place.

Clinically Relevant Size

[?]

Size Type Text
Length: 21.0 Millimeter
Outer Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: cb863b04-e0bd-476e-a4b7-bc612ab0a0c7
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: January 12, 2018

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(855)916-3876
Email: NVCustomerService@stryker.com

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