FDA.reportPublic FDA data

Curaplex

Primary DI
00812574026092
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-H1126-2
Catalog number
301-H1126-2
Device description
Curaplex Penlite LED Handle
Published
2017-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00812574026108PackageGS120In Commercial Distribution
00818834020459PackageGS16In Commercial Distribution
00812574026092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574026108008125740261088125740261080812574026108
00818834020459008188340204598188340204590818834020459
00812574026092008125740260928125740260920812574026092

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, single-useA clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the 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 single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
010712461
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing 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
00812574025804Curaplex301-P3000EA2016-12-16
00812574025828Curaplex301-P3001EA2016-12-16
00812574025842Curaplex301-P3002EA2016-12-16
00818834020466Curaplex301-180U301-180U2019-02-10
00818834020473Curaplex301-181U301-181U2019-02-10
00818834020480Curaplex301-182U301-182U2019-02-10
00818834020510Curaplex301-189U301-189U2019-02-10
00818834020718Curaplex301-104301-1042019-02-10
00818834020817Curaplex301-122EA301-122EA2019-02-10
00818834020909Curaplex301-170EA301-170EA2019-02-10
00818834020923Curaplex301-180EA301-180EA2019-02-10
00818834020954Curaplex301-181EA301-181EA2019-02-10
00818834020961Curaplex301-182EA301-182EA2019-02-10
00818834020978Curaplex301-183301-1832019-02-10
00818834020985Curaplex301-184301-1842019-02-10
00818834020992Curaplex301-189301-1892019-02-10
00818834021005Curaplex301-191301-1912019-02-10
00812574025811Curaplex301-P3000EA2016-12-14
00812574025835Curaplex301-P3001EA2016-12-14
00812574025859Curaplex301-P3002EA2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810071638688CuraplexBOUND TREE MEDICAL, LLCCCW2026-10-21
15056094505435PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505480PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505497PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505319PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505326PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505333PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505340PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505357PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505364PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505371PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505395PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505401PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505418PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505425PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505456PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505463PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505470PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
00190776434038MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434045MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434052MillenniumAvalign Technologies, Inc.CCW2026-10-09
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30