FDA.reportPublic FDA data

AngioSystems Tray

Primary DI
00816611026434
Brand
AngioSystems Tray
Company
ANGIOSYSTEMS, INCORPORATED
Model
1056-1
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905462000PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURESAngiosystems, Inc.1991-02-06LRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816611026441PackageGS125In Commercial Distribution
00816611026434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816611026441008166110264418166110264410816611026441
00816611026434008166110264348166110264340816611026434

Regulatory Flags#

DUNS number
144884467
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816611026663AngioSystems SorbXSX1000SX10002026-09-29
00816611026649AngioSystems TrayKM5043-22026-09-22
00816611026557AngioSystems TrayKM5024-82025-06-25
00816611026564AngioSystems TrayKM5024-82025-06-25
00816611026533AngioSystems Tray702770272025-05-09
00816611026540AngioSystems Tray702770272025-05-09
00816611026519AngioSystems Tray70212025-04-14
00816611026526AngioSystems Tray70212025-04-14
00816611026496AngioSystems Drape3605-023605-022025-04-02
00816611026502AngioSystems Drape3605-023605-022025-04-02
00816611026472AngioSystems Drape3270NS2025-02-07
00816611026489AngioSystems Drape3270 2025-02-07
10816611026479AngioSystems Drape3270NS2025-02-07
10816611026486AngioSystems Drape3270 2025-02-07
00816611026007AngioSystems Tray5743-52025-01-31
00816611026021AngioSystems Tray5744-52025-01-31
00816611026366AngioSystems Tray7020-32025-01-31
00816611026373AngioSystems Tray5621-82025-01-31
00816611026380AngioSystems TrayKM5061-12025-01-31
00816611026397AngioSystems TrayKM5032-52025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311264858Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264865Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264872Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264889Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264896Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264902Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264919Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264926Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264933Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264940Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264957Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264964Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264971Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264988Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264995Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265015Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265022Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265039Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265046Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00810017915194ALIF, Disc Prep Bottom LevelELEVATION SPINE, INC.LRP2026-10-30
00642356007298Mastel SurgicalMastel Surgical Inc.LRP2026-10-29
10198956566576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956589612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956593879CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956601550CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956608078CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956609037CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956620421CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623262CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29