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
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

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