Identity
- Trade Name
- SilhouetteStar FDA UDI
- Generic Name
- Wound measure FDA UDI
- Device Name
- SilhouetteStar™ is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a USB cable. FDA UDI
- Model / Reference
- 2005.01 FDA UDI
- Description
- SilhouetteStar™ is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a USB cable. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09420071400010 FDA UDI
- FDA Product Code
- FXN FDA UDI
- GMDN Term
- Wound measure FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound measure
SilhouetteStar by Aranz Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound measure.
- Wound Measuring Guide — TRADEMARK MEDICAL, L.L.C. · Class I
- Centurion — Centurion Medical Products · Class I
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class I
- Measure-it® — Derma Sciences Canada, Inc · Class I
- Swift Skin and Wound — Swift Medical, Inc. · Class I
- Centurion — Centurion Medical Products · Class I
- Healogics Photo+ — Swift Medical, Inc. · Class I
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY · 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
- Aranz Medical Limited
Sources (1)
- FDA UDI 58c09bac-ef1c-47b9-aebd-1b1108c36bcc 34 fields · synced May 30, 2026