AccessGUDID - DEVICE: SIR-Spheres Delivery Apparatus (00850014612047)

GUDID

Device Identifier (DI) Information

Brand Name: SIR-Spheres Delivery Apparatus
Version or Model: SIR-B001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIRTEX MEDICAL PTY LTD

Primary DI Number: 00850014612047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 755092467 *Terms of Use

Device Description: Delivery Apparatus for the administration of SIR-Spheres

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:	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?
40905	Radiation shielding container, general-purpose	A radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility. The design typically incorporates lead shielding or plastic materials of sufficient thickness to attenuate a specified level of radioactivity. This GMDN code does not include special purpose containers designed as vial or syringe shields or transportation/transfer containers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, Protective, Personnel

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: 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: f861ef70-b387-4441-a544-15514c771cf3
Public Version Date: January 19, 2022
Public Version Number: 2
DI Record Publish Date: July 14, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-474-7839
Email: info-us@sirtex.com

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