Identity
- Trade Name
- Impressions Shell FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Impressions Shell Kit FDA UDI
- Model / Reference
- 110 KIT FDA UDI
- Description
- Impressions Shell Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293024843 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 Shell by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External breast prosthesis.
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- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- Trulife — TRULIFE LIMITED · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- Bodicool Triangle — TRULIFE LIMITED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trulife, Inc.
Sources (1)
- FDA UDI 0e88ada7-2ad4-4b26-a299-4954c820a528 33 fields · synced Jun 4, 2026