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
00198506093746ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-22
00642356005645SteriBestMastel Surgical Inc.LRP2026-07-22
00840311264032Cortera Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-07-20
10198956493353CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956501836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956514683CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956516762CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956518896CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956519589CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956528093CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956529182CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532502CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532779CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532786CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533516CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533752CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956535091CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956493612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956501973CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956526181CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956530935CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956531925CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09