FDA.reportPublic FDA data

Bioguard Packing Strip

Primary DI
00809958087824
Brand
Bioguard Packing Strip
Company
Derma Sciences Canada Inc
Model
97832
Catalog number
97832
Device description
Bioguard Packing Strip 1/2 in x 5 yds (1.27 cm x 4.5 cm)
Published
2016-09-22
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

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
00809958087824PackageGS112In Commercial Distribution
00809958087800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958087824008099580878248099580878240809958087824
00809958087800008099580878008099580878000809958087800

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
DM exempt
false
Premarket exempt
false
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
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
00809958087107Bioguard Gauze SpongesDerma Sciences Canada IncNYS2016-09-22
00809958087305Bioguard Conforming BandageDerma Sciences Canada IncNYS2016-09-22
00809958087701Bioguard 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