FDA.reportPublic FDA data

Curaplex

Primary DI
00812277038248
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-FO-PH-1
Catalog number
301-FO-PH-1
Device description
PHILLIPS 1,BLADE,DISP.,CURAVIEW FO,GREEN SYSTEM
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071630378PackageGS16In Commercial Distribution
00812277039504PackageGS120In Commercial Distribution
00812277038248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071630378008100716303788100716303780810071630378
00812277039504008122770395048122770395040812277039504
00812277038248008122770382488122770382480812277038248

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
G14140464270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-05
G1414046400Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464290Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046430Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G141404643850Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464390Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03