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Envision ASY-14627

by Hologic United States GUDID

Product code OTE

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15420045516304 UDI-DIDate13 Nov 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
Envision
Generic Name
Radiological breast positioner, non-wearable
Model / Ref / Catalog
ASY-14627
Primary DI / UDI-DI
15420045516304
FDA Product Code
OTE
GMDN Term
Radiological breast positioner, non-wearable
Device Class
Class III
Commercial Distribution
In Commercial Distribution

Other devices from Hologic

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 2f1d2b80-2966-4b94-b04a-ddc3d134be5e 34 fields · synced 23 Oct 2026