AccessGUDID - DEVICE: BMT Fiducial Needle, Round (00860003072769)

GUDID

Device Identifier (DI) Information

Brand Name: BMT Fiducial Needle, Round
Version or Model: 80-FN1720
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONCURE ONCOLOGY, INC.

Primary DI Number: 00860003072769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056124661 *Terms of Use

Device Description: No description.

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?
38299	Manual brachytherapy system	An assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in appliances and applicators for either permanent or temporary delivery at the topical, interstitial, intraluminal, or intracavitary brachytherapy treatment site. The radioactive source(s) assemblies contain naturally occurring, reactor produced, or accelerator produced radionuclides that are in the form of, e.g., encapsulated, embedded, sealed, wire, plated or foil sources, contained radioactive liquids, gels or gas.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWJ	System, Applicator, Radionuclide, Manual

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: 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: 7f182c60-69c5-4182-8f73-4eb84d97383a
Public Version Date: September 29, 2021
Public Version Number: 3
DI Record Publish Date: August 05, 2020

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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