AccessGUDID - DEVICE: SightRail™ (M2045500080)

GUDID

Device Identifier (DI) Information

Brand Name: SightRail™
Version or Model: 550-008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 550-008
Company Name: Spectranetics Corporation

Primary DI Number: M2045500080
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: SightRail™ Manual Dilator Sheath

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:	Yes
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?
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133631	000

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
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 0.107 Inch

Device Record Status

Public Device Record Key: e4e5207d-5ae5-4071-9b95-a2e9565b6137
Public Version Date: October 26, 2021
Public Version Number: 5
DI Record Publish Date: August 26, 2014