AccessGUDID - DEVICE: ASSI (00841645116097)

GUDID

Device Identifier (DI) Information

Brand Name: ASSI
Version or Model: ASSI.AB22626
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION

Primary DI Number: 00841645116097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055870299 *Terms of Use

Device Description: Lalonde Breast Sizer Large, Size 3 500cc, Pat. Pend.

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:	No
Prescription Use (Rx):	No
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?
46179	Noninvasive breast implant sizer	A clinical instrument typically used by a surgeon during breast reconstruction surgery consultation and/or preoperative planning as a guide to select an appropriately-sized breast implant (mammary prosthesis) and tissue expander. It is typically a transparent anatomical template used with other devices (e.g., calliper, measuring tape) to measure various dimensions of the patient's existing breast (e.g., width, height, projection) for selection of the optimal expander/prosthesis to achieve symmetry with reconstruction. The device is provided in a range of dimensions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 4aba265e-b9fc-4f7d-abcd-587165b070e6
Public Version Date: June 25, 2020
Public Version Number: 1
DI Record Publish Date: June 17, 2020