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Aztec 10-18100

by Aztecmed/Ent LLC

Aztec 10-18100 is a Class I device made by Aztecmed/Ent LLC, listed in FDA GUDID since 6 Oct 2020 (UDI-DI B87110181000), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB87110181000 UDI-DI Date6 Oct 2020ListedStatusListed 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  • Withdrawn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
Aztec
Generic name
ENT probe, reusable
Model / Ref / Catalog
10-18100
Primary DI / UDI-DI
B87110181000
FDA product code
JYL
GMDN term
ENT probe, reusable
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under ENT probe, reusable.

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Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)