AccessGUDID - DEVICE: Natrelle INSPIRA Breast Implants (10888628006645)

GUDID

Device Identifier (DI) Information

Brand Name: Natrelle INSPIRA Breast Implants
Version or Model: SRL-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRL-110
Company Name: Allergan, Inc.

Primary DI Number: 10888628006645
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144796497 *Terms of Use

Device Description: NATRELLE INSPIRA Sty SRL-110 Low profile |smooth|round|silicone

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:	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?
64081	Silicone gel-filled breast implant, smooth-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020056	026

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: 110 cc

Device Record Status

Public Device Record Key: f86d9203-36ea-4381-ad3f-29fb2ce18f98
Public Version Date: April 19, 2022
Public Version Number: 3
DI Record Publish Date: May 08, 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: 8006244261
Email: ProductSupport@allergan.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES