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
00817617020389Curaplex680154-KIT680154-KIT2016-12-14
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538944HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538982HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538586HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538623HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538180HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538302HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538463HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538500HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160537619HalyardAVID MEDICAL, INC.OKV2026-09-19
10809160537800HALYARDAVID MEDICAL, INC.OKV2026-09-19
10809160536568HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160536650HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537008HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537022HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537053HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160532690HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532805HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532843HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532850HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532881HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160531853HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531938HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531969HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532027HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532065HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532096HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531747HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531761HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531327HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160531402HalyardAVID MEDICAL, INC.OKV2026-08-21