AccessGUDID - DEVICE: SIENTRA Tissue Expander (00812790022601)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Tissue Expander
Version or Model: 810-105U3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 810-105U3
Company Name: Sientra, Inc.

Primary DI Number: 00812790022601
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Tissue Expander, Rectangular, 3-Valves, Smooth, 105 ml

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
45187	Skin-port tissue expander	An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LCJ	Expander, Skin, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981852	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
Total Volume: 105 Milliliter

Device Record Status

Public Device Record Key: 5aad3363-d19d-4312-abed-e6af2180f830
Public Version Date: October 25, 2023
Public Version Number: 6
DI Record Publish Date: October 23, 2015