Identity
- Trade Name
- Sublime FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Sublime Cover Size 8 FDA UDI
- Model / Reference
- C15008 FDA UDI
- Description
- Sublime Cover Size 8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293026014 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
Sublime by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External breast prosthesis.
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- Bodicool Wave Triangle — TRULIFE LIMITED · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trulife, Inc.
Sources (1)
- FDA UDI b09a6e1c-ab09-40e6-b67e-a3a3b0d2eb6e 33 fields · synced Jun 4, 2026