FDA.reportPublic FDA data

Curaplex

Primary DI
00817617024066
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
2145-13404
Catalog number
2145-13404
Device description
Curaplex Select Laryngoscope Blade, Mac 4, LED, Disposable 20ea/bx
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00817617024066PackageGS120In Commercial Distribution
00817617024059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617024066008176170240668176170240660817617024066
00817617024059008176170240598176170240590817617024059

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel 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 has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089633ELMED INCORPORATEDELMED INCORPORATEDCCW2026-03-17
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00198506088063ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-22
00198506087868ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087882ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087905ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
05707480164264Ambu® SureSight® Data CableAmbu A/SCCW2025-12-19
05707480164301Ambu® SureSight® Battery ChargerAmbu A/SCCW2025-12-19
09348811110183INKAThe Trustee for KAISER FAMILY TRUSTCCW2025-11-25
10884521849761McGRATH MAC+Covidien LPCCW2025-11-17
00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
04250676716095Surgical laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-19
04250381858431Laser laryngoscope, size 1, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858448Laser laryngoscope, size 2, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858455Laser laryngoscope, size 3, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858462Laser laryngoscope, size 4, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858479Laser laryngoscope, size 5, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858486Laser laryngoscope, size 6, black, forSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858493Laser laryngoscope, size 7, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676739933Holinger laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741646Laser laryngoscope, Ulm typeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741660Smoke evacuation tubeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
00840183530662BR Surgical, LLCBR Surgical, LLCCCW2025-08-21
20197344135667MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135834MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135919MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135933MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135964MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135971MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14