← Back to catalogue

Impressions II

FDA UDI

Class I (US FDA UDI)

by Trulife Limited

Identity

Trade Name
Impressions II FDA UDI
Generic Name
External breast prosthesis FDA UDI
Device Name
Impressions II Cover Size 13 FDA UDI
Model / Reference
C10113 FDA UDI
Description
Impressions II Cover Size 13 FDA UDI

Identifiers

Primary DI / UDI-DI
00643293025291 FDA UDI
FDA Product Code
NOJ FDA UDI
GMDN Term
External breast prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External breast prosthesis

Impressions II by Trulife Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External breast prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Trulife Limited

Sources (1)

  • FDA UDI 418a2daa-bb56-4d30-af37-7b05ec3d1c5e 33 fields · synced Jun 8, 2026