FDA.reportPublic FDA data

AngioSystems Tray

Primary DI
00816611026038
Brand
AngioSystems Tray
Company
ANGIOSYSTEMS, INCORPORATED
Model
5744-5
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00816611026038PackageGS16In Commercial Distribution
00816611026021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816611026038008166110260388166110260380816611026038
00816611026021008166110260218166110260210816611026021

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144884467
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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