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
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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

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