AccessGUDID - DEVICE: Preloaded in PSS1820SL3 Square Hub Needles, 3pk (00815165020387)

GUDID

Device Identifier (DI) Information

Brand Name: Preloaded in PSS1820SL3 Square Hub Needles, 3pk
Version or Model: PSS1820SL3 Square Hub Needles, 3pk
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM0845SLS-3
Company Name: Eckert & Ziegler Bebig, Inc.

Primary DI Number: 00815165020387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021125001 *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:	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?
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: 8e893754-65b4-44d9-9e13-bcc38830ecbc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 27, 2015