AccessGUDID - DEVICE: Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP (M746SZLP683000)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP
Version or Model: SZLP68300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SZLP68300
Company Name: SPECIALTY SURGICAL PRODUCTS INC

Primary DI Number: M746SZLP683000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002112626 *Terms of Use

Device Description: Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 Low Profile, 300cc

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c5499811-f63d-43b7-a8d5-182ec1fa12ce
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: June 01, 2018