FDA.reportPublic FDA data

Curaplex

Primary DI
00810071634932
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1121-36566
Catalog number
1121-36566
Device description
Curaplex Rolled Gauze Bandage, Non-Sterile 2in 12rl/bg, 8bg/cs
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071634932PackageGS18In Commercial Distribution
00810094575182PackageGS112In Commercial Distribution
00810071634284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071634932008100716349328100716349320810071634932
00810094575182008100945751828100945751820810094575182
00810071634284008100716342848100716342840810071634284

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
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
G242YCBJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-12
G242YCAYMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCCCMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCETMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YVBRMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCADMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAKMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCASMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBOMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YVAMMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCABMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCACMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAEMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAGMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCALMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAMMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCANMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAQMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCARMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCATMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAWMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAXMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05