FDA.reportPublic FDA data

Curaplex

Primary DI
00815277023344
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
16108
Device description
Curaplex Yankauer without Vent 20ea/pk
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277023344PackageGS12In Commercial Distribution
00815277025607PackageGS110In Commercial Distribution
00815277023337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277023344008152770233448152770233440815277023344
00815277025607008152770256078152770256070815277025607
00815277023337008152770233378152770233370815277023337

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic irrigation/aspiration cannulaA rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676716880ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
04250676716897ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-29
04250381814925ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814932ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814949ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814956ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814970ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814987ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381814994ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815007ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815014ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815021ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815038ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815045ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815052ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815069ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815076ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815083ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815106ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815113ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815120ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815137ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815144ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815151ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815175ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815182ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815199ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815205ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815212ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12
04250381815229ENT-single-use suction tubes, angledSpiggle & Theis Medizintechnik GmbHBYY2025-09-12