AccessGUDID - DEVICE: Balloon Applicator Kit (00858012005342)

GUDID

Device Identifier (DI) Information

Brand Name: Balloon Applicator Kit
Version or Model: 720343
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB2063E
Company Name: Icad, Inc.

Primary DI Number: 00858012005342
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108870254 *Terms of Use

Device Description: Balloon Applicator, 5x7 cm Ellipsodial

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):	No
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?
59686	Intraoperative/postoperative therapeutic x-ray system balloon applicator kit	A sterile collection of devices that is a component of an intraoperative/postoperative therapeutic x-ray system designed for the administration of radiation in certain clinical applications, typically intraoperatively within a resected breast tumour bed. It typically consists of a set of cavity ball gauges used for measurement of the cavity, and a set of graduated size balloon applicators. The required size of applicator is intended to be placed in the tumour cavity after lumpectomy and inflated, and the inner catheter is designed to hold the tube of the x-ray source, stabilized by a probe guard, during radiotherapy treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAD	System, Therapeutic, X-Ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090914	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 787da7e0-42b8-4ac4-a9d1-0ec2c92e7296
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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