AccessGUDID - DEVICE: Beacon (00827002312166)

GUDID

Device Identifier (DI) Information

Brand Name: Beacon
Version or Model: G31216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NR5.0-35-100-P-10S-PIG-CSC-20
Company Name: COOK INCORPORATED

Primary DI Number: 00827002312166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042823948 *Terms of Use

Device Description: Beacon Tip Centimeter Sizing Catheter

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?
46450	Blood vessel sizer	A sterile surgical instrument used to perform anatomical measurement of a blood vessel (e.g., sectional length, luminal circumference) prior to an invasive diagnostic or interventional procedure (e.g., the angiographic injection of a contrast medium). It is a long, slender, flexible rod-like device that has a hollow or solid body with radiopaque markers placed at incremented intervals at the working end to make it visible on x-ray. The distal end can have a variety of sizes and shapes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, intravascular, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173289	000

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 dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21acf944-51d2-45fa-8c33-b51dffcb590b
Public Version Date: March 07, 2024
Public Version Number: 1
DI Record Publish Date: February 28, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10827002312163	5	00827002312166		In Commercial Distribution	BX

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(812)330-5494
Email: sharedservices@cookmedical.com

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