AccessGUDID - DEVICE: Natrelle INSPIRA Resterilizable Sizers (10888628009226)

GUDID

Device Identifier (DI) Information

Brand Name: Natrelle INSPIRA Resterilizable Sizers
Version or Model: MSZ-F180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSZ-F180
Company Name: Allergan, Inc.

Primary DI Number: 10888628009226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144796497 *Terms of Use

Device Description: NATRELLE INSPIRA Rester Szr Sty MSZ-F180 Full

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":	Yes
For Single-Use:	No
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?
34178	Invasive breast implant sizer, fixed, single-use	A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRD	Mammary Sizer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K831566	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 180 cc

Device Record Status

Public Device Record Key: 58e6be1f-3beb-41f2-920a-d774f947d313
Public Version Date: October 28, 2022
Public Version Number: 1
DI Record Publish Date: October 20, 2022