FDA.reportPublic FDA data

Aspen® Skin Closure

Primary DI
00840113201372
Brand
Aspen® Skin Closure
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
1047NS
Device description
Intended for skin closure and closure support for sutures and staples
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K874813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874813000OMED WOUND CLOSURE STRIPSOxboro Medical Intl., Inc.1988-01-29FPX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840113201379PackageGS15000In Commercial Distribution
00840113201372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084011320137910840113201379
00840113201372008401132013728401132013720840113201372

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840113242754BovieSEVL2026-09-18
10840113242778BovieSERFS2026-09-18
10840113242785BovieSEPAT2026-09-18
10840113242792BovieSEPA2026-09-18
10840113242983VALLEYLAB™E156042026-09-18
10840113242990VALLEYLAB™E155942026-09-18
10840113243034VALLEYLAB™E156242026-09-18
10840113243058VALLEYLAB™E156142026-09-18
10840113243072VALLEYLAB™E165142026-09-18
10840113243089VALLEYLAB™E165122026-09-18
10840113243096VALLEYLAB™E156262026-09-18
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344203547CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203554CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203561CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203578CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203585CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
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