FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021104
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
444003
Catalog number
444003
Device description
Curaplex OB Kit Poly Bagged with Umbilical Scissors
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MMPCover, barrier, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071639180PackageGS135In Commercial Distribution
00815277021104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071639180008100716391808100716391800810071639180
00815277021104008152770211048152770211040815277021104

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
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
10193489130225COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
10884389413630Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10884389413647Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10884389614600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10195327422202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10080196900701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489469455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489490497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771442Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771466Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771473Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771480Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327052584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057657Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057664Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327060084Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M752SS1707870STRADISSTRADIS MEDICAL, LLCMMP2022-05-31
M75240290SCC0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-05-27
M7521001NS0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10195327004224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10080196497591MedlineMEDLINE INDUSTRIES, INC.MMP2021-07-16
10884389028414MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
10888277677975MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
10884389029510ACCUFITMEDLINE INDUSTRIES, INC.MMP2021-01-26
10080196073160MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
10080196001804MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10884389001806MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10080196073191MedlineMEDLINE INDUSTRIES, INC.MMP2020-11-26