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Sana Beta MK4

by Sana Health

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850039306068 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sana
Generic Name
Pain relief virtual reality system
Model / Ref / Catalog
Beta MK4
Primary DI / UDI-DI
00850039306068
FDA Product Code
QYN
GMDN Term
Pain relief virtual reality system
Device Class
Class I
Regulation Number
890.5775
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Depth — 11.5 Centimeter
Height — 7.8 Centimeter
Width — 19.8 Centimeter
Weight — 200 Gram

Other devices from Sana Health

  • Sana Device

    Class I

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No