FDA.reportPublic FDA data

Curaplex

Primary DI
00815277027670
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
660205
Catalog number
660205
Device description
Curaplex 8.5 Intubation Kit
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGKOrotrachael intubation guide kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGKOrotracheal Intubation Guide KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277027670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277027670008152770276708152770276700815277027670

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricant, non-sterileA non-sterile substance intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009615533Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
00860009615540Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
00860009615557Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
00810094575588CuraplexBOUND TREE MEDICAL, LLCOGK2023-03-30
00749756364249DeRoyalDEROYAL INDUSTRIES, INC.OGK2021-05-07
50749756364244DeRoyalDEROYAL INDUSTRIES, INC.OGK2021-05-07
00191072112057ACSAMERICAN CONTRACT SYSTEMS, INC.OGK2020-05-11
00815277020596CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277022040CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277022057CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277027458CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277027656CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277027663CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277027700CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277028059CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14
00815277028073CuraplexBOUND TREE MEDICAL, LLCOGK2016-12-14