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NATRELLE Saline-Filled Breast Implants

FDA UDI

Class III (US FDA UDI)

by Allergan

Identity

Trade Name
NATRELLE Saline-Filled Breast Implants FDA UDI
Generic Name
Saline-filled breast implant, unstructured, textured-surface FDA UDI
Device Name
NATRELLE 468-350 Moderate Projection BIOCELL |textured|contour|saline FDA UDI
Model / Reference
468-350 FDA UDI
Description
NATRELLE 468-350 Moderate Projection BIOCELL |textured|contour|saline FDA UDI

Identifiers

Catalog Number
468-350 FDA UDI
Primary DI / UDI-DI
10888628001121 FDA UDI
PMA Number
P990074 FDA UDI
FDA Product Code
FWM FDA UDI
GMDN Term
Saline-filled breast implant, unstructured, textured-surface FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
878.3530 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

NATRELLE Saline-Filled Breast Implants by Allergan — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P990074 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allergan

Sources (1)

  • FDA UDI 4d1a7d0f-747d-4557-bcc6-7db73d7cfe8d 38 fields · synced May 31, 2026