FDA.reportPublic FDA data

Curaplex

Primary DI
00199972000115
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01538
Catalog number
8600-01538
Device description
*Custom* LACoFD MCI Kit (MCI - OB)
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199972000115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199972000115001999720001151999720001150199972000115

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160529362HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160529379HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160528402HalyardAVID MEDICAL, INC.OKV2026-08-03
10809160528471HalyardAVID MEDICAL, INC.OKV2026-08-03
10198956531307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956534094CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956536999CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10809160528075HalyardAVID MEDICAL, INC.OKV2026-07-29
10809160527856HalyardAVID MEDICAL, INC.OKV2026-07-28
10198956499263CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10198956510937CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10809160527702HalyardAVID MEDICAL, INC.OKV2026-07-21
10198956532250CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-20
10809160527542HalyardAVID MEDICAL, INC.OKV2026-07-20
10809160527382HalyardAVID MEDICAL, INC.OKV2026-07-17
10809160527498HalyardAVID MEDICAL, INC.OKV2026-07-17
10198956486584CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-16
10809160527269HalyardAVID MEDICAL, INC.OKV2026-07-16
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22