AccessGUDID - DEVICE: Tissue Expander Remote Port Accessories (00819409020362)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue Expander Remote Port Accessories
Version or Model: RPA01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RPA01
Company Name: Sientra, Inc.

Primary DI Number: 00819409020362
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Tissue Expander Remote Port Accessories

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":	Yes
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?
46583	Tissue expander injection port locator	A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCJ	Tissue Expander And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070303	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aae3acb5-39ee-418c-9a18-ea8c730e1df4
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: August 14, 2023