AccessGUDID - DEVICE: ViperTrack (10852528005107)

GUDID

Device Identifier (DI) Information

Brand Name: ViperTrack
Version or Model: VPR-TRK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72014-02
Company Name: Cardiovascular Systems, Inc.

Primary DI Number: 10852528005107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024954518 *Terms of Use

Device Description: VIPERTRACK, 50 PACK

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?
42303	X-ray film ruler	A device used in radiology to superimpose accurate measurements of length (i.e., inches or millimetres) onto an x-ray film so that these measurements remain as a permanent feature of that x-ray against the anatomical structure that has been captured. It is made of x-ray translucent material (e.g., plastic) whilst the graduations are not translucent and therefore show on the exposed x-ray film. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	Tape, Measuring, Rulers And Calipers

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Centimeter

Device Record Status

Public Device Record Key: cc96b814-e752-4dff-9eca-2844484d0819
Public Version Date: November 20, 2018
Public Version Number: 1
DI Record Publish Date: October 20, 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
30852528005101	50	10852528005107		In Commercial Distribution	Box

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: 651-259-1600
Email: customerservice@csi360.com

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