FDA.reportPublic FDA data

AngioSystems Tray

Primary DI
00816611026557
Brand
AngioSystems Tray
Company
ANGIOSYSTEMS, INCORPORATED
Model
KM5024-8
Published
2025-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00816611026564PackageGS120In Commercial Distribution
00816611026557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816611026564008166110265648166110265640816611026564
00816611026557008166110265578166110265570816611026557

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
144884467
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816611026649AngioSystems TrayKM5043-22026-09-22
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
00816611026410AngioSystems Tray5734-12025-01-31
00816611026427AngioSystems Drape3432-022025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219289043LANDANGERLANDANGERLRP2026-09-27
10198956383043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956535428CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956589193CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590267CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956591554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956592216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956592827CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956593336CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956594555CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595118CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595125CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595804CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596108CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596115CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596184CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597501CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597839CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597969CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956598836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
00816611026649AngioSystems TrayANGIOSYSTEMS, INCORPORATEDLRP2026-09-22
10198956446953CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956486294CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956520240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956570191CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578371CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22