FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021067
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
444001
Device description
Curaplex OB Kit Poly Bagged with Scalpel
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
false
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
00810071639166PackageGS135In Commercial Distribution
00815277021067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071639166008100716391668100716391660810071639166
00815277021067008152770210678152770210670815277021067

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814707023817ProtekASPEN SURGICAL PRODUCTS, INC.MMP2026-02-16
00850061871053IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-23
00850061871039IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-22
40193489130226COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
40884389413631Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389413648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389614601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40195327422203Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10193489189223MedlineMEDLINE INDUSTRIES, INC.MMP2022-11-10
40080196900702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489469456Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489490498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327052585Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057405Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057665Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327060085Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M7521001NS1Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10810050854174Typenex Extubation BibTYPENEX MEDICAL LLCMMP2022-04-04
00850977007881IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2021-12-14
40195327004409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10193489400625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-07-04
40193489437127MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
20888277677972MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
40080196073161MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31