FDA.reportPublic FDA data

Burn Sheet, Sterile

Primary DI
00616784352015
Brand
Burn Sheet, Sterile
Company
Dynarex Corporation
Model
3520
Device description
"Burn Sheet, Sterile 60""x90"""
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBYCooler, Esophageal And Gastric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBYCooler, Esophageal And GastricUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784352039PackageGS112In Commercial Distribution
00616784352015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784352039006167843520396167843520390616784352039
00616784352015006167843520156167843520150616784352015

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117348707dmecare Solutions Elongated Folding Bedside Commode, With Collapsible Bucket10373C2026-10-30
00840117310346Resp-O2 Oxygen Cylinder Cart, Single366202026-10-28
00840117310353Resp-O2 Oxygen Cylinder Cart, Dual366212026-10-28
00840117310360Resp-O2 Oxygen Cylinder Holder, Wheelchair Mount366222026-10-28
00840117310278Resp-O2 Oxygen Cylinder Wrenches, Black366002026-10-26
00840117346222Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Post Valve, 4.55 L36390-PBULK2026-10-26
00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784353111Multi-Trauma DressingDynarex CorporationFBY2021-06-21
00616784352039Burn Sheet, Sterile DYNAREX CORPORATIONFBY2021-06-21
00616784353135Multi-Trauma DressingDYNAREX CORPORATIONFBY2021-06-21