AccessGUDID - DEVICE: Misago® (04987350722201)

GUDID

Device Identifier (DI) Information

Brand Name: Misago®
Version or Model: SXR07080L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SX*FXA0780LN
Company Name: TERUMO CORPORATION

Primary DI Number: 04987350722201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: MISAGO RX Self-expanding Peripheral Stent

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?
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIP	Stent, Superficial Femoral Artery

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: Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Distal Tip and Sheath are coated with Hydrophilic Polymer
Device Size Text, specify: Catheter Usable Length: 135 centimeters
Length: 80 Millimeter
Lumen/Inner Diameter: 7 Millimeter

Device Record Status

Public Device Record Key: 7e057278-a9d7-4235-9c8b-c058a254ca83
Public Version Date: February 03, 2023
Public Version Number: 6
DI Record Publish Date: May 30, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
54987350722206	5	04987350722201		In Commercial Distribution	Carton

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)283-7866
Email: tmccustomer.admin@terumomedical.com

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