AccessGUDID - DEVICE: Bexa Pressure Mapping System (00860000501729)

GUDID

Device Identifier (DI) Information

Brand Name: Bexa Pressure Mapping System
Version or Model: 1885
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURE INC.

Primary DI Number: 00860000501729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116944848 *Terms of Use

Device Description: Breast lesion documentation system

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
57820	Electronic clinical breast examination system	A portable assembly of devices designed to electronically measure, map, document and store information about breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE). It is typically used by physicians/clinical practitioners that perform CBE during breast cancer screening and evaluation of suspected breast masses. It typically consists of a hand-held applicator (tactile receptor containing pressure transducers), a portable computer, application software, and a calibrator. Scanning is performed over the entire breast or an area of interest and is typically displayed as a colour map differentiating the tissues.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKA	System, Documentation, Breast Lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181672	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: d03c2045-36b0-4a12-826e-715cd552c254
Public Version Date: November 05, 2021
Public Version Number: 1
DI Record Publish Date: October 28, 2021

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (833) 787-3462
Email: info@mybexa.com

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