FDA.reportPublic FDA data

Purilon

Primary DI
00762123018187
Brand
Purilon
Company
Coloplast A/S
Model
3903
Catalog number
3903
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAEDressing, wound, hydrogel without drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123018187PackageGS110In Commercial Distribution
00762123018194PackageGS124In Commercial Distribution
05708932759564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123018187007621230181877621230181870762123018187
00762123018194007621230181947621230181940762123018194
05708932759564057089327595645708932759564

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight25Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975278040017delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040024delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040031delay cream/delay balm for menJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040048vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040055vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040062vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040079vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040086vaginal pleasure liquibead/climax intense liquibeadJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040116vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040123vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040130vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
00743537000449First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000715MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00860000562539LaviorLavior Pharma Inc.NAE2026-02-14
00860007877766LaviorLavior Pharma Inc.NAE2026-02-14
00860007877773LaviorLavior Pharma Inc.NAE2026-02-14
00860010195727LaviorLavior Pharma Inc.NAE2026-02-14
00860010195741LaviorLavior Pharma Inc.NAE2026-02-14
00850072068749CeladiaBiowound Solutions, Inc.NAE2025-12-18
06972864363031sknjxNingbo Chinmed Technology Co., Ltd.NAE2025-12-16
50192253040157KendallCardinal Health 200, LLCNAE2025-09-26
00197998326905Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00197998326981Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz TubeKericure Inc.NAE2025-08-26
07290101428350Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
72901014283670Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
15056860000072Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000089Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
00858071004317Advanced Shield Chronic Wound Care, 2ozKericure Inc.NAE2025-08-08
00860000495097Altrazeal Transforming Powder DressingAltrazeal Life Sciences Inc.NAE2025-08-07