AccessGUDID - DEVICE: Natrelle Inspira ST Resterilizable Sizers (10888628031937)

GUDID

Device Identifier (DI) Information

Brand Name: Natrelle Inspira ST Resterilizable Sizers
Version or Model: MSZST-M445
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSZST-M445
Company Name: Allergan, Inc.

Primary DI Number: 10888628031937
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144796497 *Terms of Use

Device Description: Natrelle Inspira RS Sizer - ST M445

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	Sizer, Mammary, Breast Implant Volume

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 445 cc

Device Record Status

Public Device Record Key: 110fffac-17a5-4751-ace6-2342d58f2530
Public Version Date: December 21, 2020
Public Version Number: 4
DI Record Publish Date: October 05, 2016