FDA.reportPublic FDA data

Curaplex

Primary DI
00812277037876
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-FO-M
Catalog number
301-FO-M
Device description
HANDLE,MINI,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
00810071630040PackageGS16In Commercial Distribution
00812277039139PackageGS120In Commercial Distribution
00812277037876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071630040008100716300408100716300400810071630040
00812277039139008122770391398122770391390812277039139
00812277037876008122770378768122770378760812277037876

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, reusableThe hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be 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
10884521859999McGRATH MAC+Covidien LPCCW2026-07-03
04053755200122visionPRO Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-24
04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00810055257607Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257621Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257638Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257645Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257652Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257669Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257676Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257683Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257690Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257706Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257713Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257720Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257737Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251346Surgical DesignSurgical Design, Inc.CCW2026-06-09