AccessGUDID - DEVICE: Natrelle Inspira Cohesive Breast Implants (10888628029910)

GUDID

Device Identifier (DI) Information

Brand Name: Natrelle Inspira Cohesive Breast Implants
Version or Model: SCM-375
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCM-375
Company Name: Allergan, Inc.

Primary DI Number: 10888628029910
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144796497 *Terms of Use

Device Description: Natrelle Inspira SCM 375cc Moderate 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

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FDA Product Code

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

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020056	034

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
No storage/handling found

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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 375 cc

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

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

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

Customer Contact

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DEVICE: Natrelle Inspira Cohesive Breast Implants (10888628029910)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact