FDA.reportPublic FDA data

AngioSystems Tray

Primary DI
00816611026649
Brand
AngioSystems Tray
Company
ANGIOSYSTEMS, INCORPORATED
Model
KM5043-2
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00816611026656PackageGS120In Commercial Distribution
00816611026649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816611026656008166110266568166110266560816611026656
00816611026649008166110266498166110266490816611026649

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816611026410AngioSystems Tray5734-12025-01-31
00816611026427AngioSystems Drape3432-022025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956579644CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588042CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588868CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588875CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589070CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589148CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589155CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589483CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589636CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956590342CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956591561CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592834CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592995CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593312CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593329CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594067CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594456CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594708CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956587861CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-21
10198956588585CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-21