AccessGUDID - DEVICE: IDEAL IMPLANT (10851795006114)

GUDID

Device Identifier (DI) Information

Brand Name: IDEAL IMPLANT
Version or Model: 59501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 595
Company Name: IDEAL IMPLANT INCORPORATED

Primary DI Number: 10851795006114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005225418 *Terms of Use

Device Description: Round, smooth-surface, saline-filled breast implant.

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?
36196	Saline-filled breast implant, unstructured	A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FWM	Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120011	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: Total Volume, 595 cc

Device Record Status

Public Device Record Key: ffe23f48-9bed-4fec-88b9-008e7b2ddaba
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: September 09, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 214-492-2500
Email: info@idealimplant.com

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