AccessGUDID - DEVICE: SIENTRA Gluteal Implant (00812790023004)

GUDID

Device Identifier (DI) Information

Brand Name: SIENTRA Gluteal Implant
Version or Model: 20922-168U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20922-168U
Company Name: Sientra, Inc.

Primary DI Number: 00812790023004
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: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 385 cc

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?
45230	Silicone-block tissue reconstructive material	A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIB	Elastomer, Silicone Block

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974482	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
Device Size Text, specify: Volume: 385 cc

Device Record Status

Public Device Record Key: 2c49c4bf-b2b0-43f9-ad1e-20a632f8a30b
Public Version Date: October 25, 2023
Public Version Number: 5
DI Record Publish Date: October 23, 2015