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El Capitan KZA010000

by Astura Medical United States GUDID

Product code OVD

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840085217876 UDI-DIDate3 Aug 2021ListedStatusIn 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
El Capitan
Generic Name
Bone marker
Model / Ref / Catalog
KZA010000
Primary DI / UDI-DI
00840085217876
FDA Product Code
OVD
GMDN Term
Bone marker
Device Class
Class II
Regulation Number
888.3080
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Bone marker

Other devices from Astura Medical

See all devices from Astura Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
Other properties (11)
  • Sterile: 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
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 29376ed6-8d42-449c-8013-de625625849f 35 fields · synced 23 Oct 2026