FDA.reportPublic FDA data

Curaplex

Primary DI
00817617025001
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36002MS
Catalog number
36002MS
Device description
IV Guard Dressing, Medstorm Label
Published
2017-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing,wound,hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817617023731PackageGS1100In Commercial Distribution
00817617025001PackageGS15In Commercial Distribution
00817617023250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617023731008176170237318176170237310817617023731
00817617025001008176170250018176170250010817617025001
00817617023250008176170232508176170232500817617023250

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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
07333350377205Mepore®Mölnlycke Health Care ABNAC2026-05-23
07333350625993Mepore®Mölnlycke Health Care ABNAC2026-05-23
00361554003412Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003436Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003450Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
20197344025340MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-13
30197344016840MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
30197344016857MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
07333350045845Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
07333350416249Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
20665973033024DukalDukal LLCNAC2026-02-26
00197998275326Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275951Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275999Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
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00197998276071Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276118Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276156Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276194Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276231Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276279Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276316Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00810178883646ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883653ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883660ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883677ViveCareVIVE HEALTH LLCNAC2026-02-05
20197344016812MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
20197344016836MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
00198926007453OrchidQuest USA Corp.NAC2026-02-03
00198926007460OrchidQuest USA Corp.NAC2026-02-03