FDA.reportPublic FDA data

hole-in-none

Primary DI
00850045406059
Brand
hole-in-none
Company
General Hospital Supply Corp
Model
4800
Catalog number
4800
Device description
Edge Guard
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045406059PrimaryGS10
10850045406056Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045406059008500454060598500454060590850045406059
1085004540605610850045406056

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray corner protector, reusableA device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a reusable device.

Regulatory Flags#

DUNS number
055852834
Device count
48
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045406035rack-n-stack011701172022-09-14
00850045406011rack-n-stack010801082022-09-14
00850045406004rack-n-stack010201022022-09-12
00850045406592bio-trayBT-1121BT-11212024-08-15
10850045406599bio-trayBT-1121BT-11212024-08-15
00850045406585triple-liner602260222023-08-17
10850045406582triple-liner602260222023-08-17
00850045406028rack-n-stack011201122022-09-14
00850045406257fold-n-hold089508952022-09-20
00850045406264fold-n-hold081208122022-09-20
00850045406271fold-n-hold050505052022-09-20
00850045406288fold-n-hold041704172022-09-20
00850045406295fold-n-hold101010102022-09-20
00850045406387plasma-tazzS0607S06072022-09-20
00850045406394plasma-tazzS0810S08102022-09-20
00850045406400plasma-tazzS3511S35112022-09-20
00850045406417plasma-tazzS3517S35172022-09-20
00850045406424count-me-outCMO-10CMO-102022-09-20
00850045406431count-me-outCMO-11CMO-112022-09-20
00850045406448count-me-outCMO-15CMO-152022-09-20

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