FDA.reportPublic FDA data

Bioguard Gauze Sponges

Primary DI
00809958087107
Brand
Bioguard Gauze Sponges
Company
Derma Sciences Canada Inc
Model
97412
Catalog number
97412
Device description
Bioguard Gauze Sponges, 12 Ply - USP Type VII Gauze, 4 in x 4 in (10 cm x 10 cm)
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)General, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958087114PackageGS125In Commercial Distribution
00809958087121PackageGS124In Commercial Distribution
00809958087107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958087114008099580871148099580871140809958087114
00809958087121008099580871218099580871210809958087121
00809958087107008099580871078099580871070809958087107

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic nanofiber barrier dressingA sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-825-4325cs@dermasciences.com

Regulatory Flags#

DUNS number
200564891
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00809958093108Ducare®9409SDUP9409S2019-03-06
00809958013502Dupress®11903DUP119032018-11-13
00809958013601Dupress®11904DUP119042018-11-13
00809958013809Dupress®11907DUP119072018-10-23
00809958013908Dupress®11908DUP119082018-10-23
00809958080115DuCare®82208DUP822082018-10-23
00809958080214DuCare®82212DUP822122018-10-23
00809958080412DuCare®82312DUP823122018-10-23
00809958080511DuCare®82408DUP824082018-10-23
00809958080610DuCare®82412DUP824122018-10-23
00809958080719DuCare®82812DUP828122018-10-23
00809958080818DuCare®82815DUP828152018-10-23
00809958082010DuCare®82910DUP829102018-10-23
00809958084113DuCare®82410DUP824102018-11-20
00809958087411PrimaPad®83338DUP833382018-10-23
00809958087510PrimaPad®83334DUP833342018-10-23
00809958087619PrimaPad®83323DUP833232018-10-23
00809958090510DuCare®90208DUP902082018-11-13
00809958090619DuCare®90212DUP902122018-11-13
00809958090718DuCare®90308DUP903082018-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00809958088906Bioguard Burn Dressing - Ready-Cut GauzeDerma Sciences Canada IncNYS2017-01-16
00809958087800Bioguard Packing StripDerma Sciences Canada IncNYS2016-09-22
00809958015506Bioguard Non-Adherent DressingDerma Sciences Canada IncNYS2016-09-22
00809958086803Bioguard Large Roll - Gauze BandageDerma Sciences Canada IncNYS2016-09-22
00809958087008Bioguard Gauze SpongesDerma Sciences Canada IncNYS2016-09-22
00809958087305Bioguard Conforming BandageDerma Sciences Canada IncNYS2016-09-22
00809958087701Bioguard Packing StripDerma Sciences Canada IncNYS2016-09-22
00809958087824Bioguard Packing StripDerma Sciences Canada IncNYS2016-09-22
00809958087909Bioguard Packing StripDerma Sciences Canada IncNYS2016-09-22
00809958088203Bioguard Non-Adherent DressingsDerma Sciences Canada IncNYS2016-09-22
00809958088302Bioguard Island DressingDerma Sciences Canada IncNYS2016-09-22
00809958088401Bioguard Island DressingDerma Sciences Canada IncNYS2016-09-22
00809958088500Bioguard Island DressingDerma Sciences Canada IncNYS2016-09-22
00809958088609Bioguard Island DressingDerma Sciences Canada IncNYS2016-09-22
00809958088708Bioguard Conforming BandageDerma Sciences Canada IncNYS2016-09-22
00809958088807Bioguard Conforming BandageDerma Sciences Canada IncNYS2016-09-22