AccessGUDID - DEVICE: SIENTRA Chin Implant (00812790023219)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Chin Implant
Version or Model: 15-060U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 15-060U
Company Name: Sientra, Inc.

Primary DI Number: 00812790023219
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: Chin Implant, Solid Silicone, Anatomical, Smooth, 61 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35261	Chin prosthesis	A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FWP	Prosthesis, Chin, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981850	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
Length: 61 Millimeter

Device Record Status

Public Device Record Key: 4b8a0077-9019-411c-96cb-af08ef1d1184
Public Version Date: October 25, 2023
Public Version Number: 6
DI Record Publish Date: October 23, 2015