FDA.reportPublic FDA data

steam-n-lene

Primary DI
00850045406080
Brand
steam-n-lene
Company
General Hospital Supply Corp
Model
1216
Catalog number
1216
Device description
Tray Liner 12 x 16
Published
2022-09-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045406080PrimaryGS10
10850045406087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045406080008500454060808500454060800850045406080
1085004540608710850045406087

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray linerA durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp clinical instruments (typically endoscopes or surgical instruments) and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device.

Regulatory Flags#

DUNS number
055852834
Device count
100
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