FDA.reportPublic FDA data

Shur-Strip®

Primary DI
00809958181515
Brand
Shur-Strip®
Company
Derma Sciences Canada Inc
Model
81121
Catalog number
DKC81121
Device description
Shur Strip Sterile Skin Closures
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPXStrip, adhesive, closure, skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPXStrip, Adhesive, Closure, SkinGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894205000TECNOL SILK STRIPTecnol New Jersey Wound Care, Inc.1989-07-25FPX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958181515PrimaryGS10
00809958181508Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958181515008099581815158099581815150809958181515
00809958181508008099581815088099581815080809958181508

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
200564891
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00050428344781CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFPX2026-05-25
30197344203530CURADMEDLINE INDUSTRIES, INC.FPX2026-05-15
00194346192038EquateWAL-MART STORES, INC.FPX2024-02-15
20194346192032EquateWAL-MART STORES, INC.FPX2024-02-15
10849233004822Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233004874Busse Hospital DisosablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004884Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004891Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233005000Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
00017276239287Care ScienceAso LLCFPX2023-06-08
20017276239281Care ScienceAso LLCFPX2023-06-08
10665973008803DukalDukal LLCFPX2022-12-06
10665973008810DukalDukal LLCFPX2022-12-06
10665973008827DukalDukal LLCFPX2022-12-06
10665973008834DukalDukal LLCFPX2022-12-06
10665973008841DukalDukal LLCFPX2022-12-06
10665973008858DukalDukal LLCFPX2022-12-06
20665973008800DukalDukal LLCFPX2022-12-06
20665973008817DukalDukal LLCFPX2022-12-06
20665973008824DukalDukal LLCFPX2022-12-06
20665973008831DukalDukal LLCFPX2022-12-06
30665973008845DukalDukal LLCFPX2022-12-06
30665973008852DukalDukal LLCFPX2022-12-06
00840986021558Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
10840986021555Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
H65890043141Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043151Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043161Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043171Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043181Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22