AccessGUDID - DEVICE: TheraSeed® (00801741078521)

GUDID

Device Identifier (DI) Information

Brand Name: TheraSeed®
Version or Model: TS200RL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TS200RL
Company Name: Bard Brachytherapy, Inc.

Primary DI Number: 00801741078521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185524860 *Terms of Use

Device Description: Model 200 TheraSeed™ Palladium-103 in ReadyLink™

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:	Yes
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?
38303	Manual brachytherapy source, permanent implant	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.	Active	true
46844	Brachytherapy source spacer	A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, brachytherapy, radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060636	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
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0785633-1e7d-4a7f-b2ee-daf5530218d2
Public Version Date: August 28, 2024
Public Version Number: 5
DI Record Publish Date: October 05, 2015

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

Customer Contact

[?]

Phone: +1(800)977-6733
Email: medical.services@crbard.com

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