FDA.reportPublic FDA data

Silon-TSR 5x5

Primary DI
00810050460019
Brand
Silon-TSR 5x5
Company
Bio Med Sciences, Inc.
Model
2025P
Catalog number
2025P
Device description
Perforated Temporary Skin Replacement
Published
2023-08-04
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
MGPDressing, Wound And Burn, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923150000SILON TRANSPARENT WOUND DRESSINGSBio Med Sciences, Inc.1992-08-27MGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050460016PackageGS110In Commercial Distribution
00810050460019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005046001610810050460016
00810050460019008100504600198100504600190810050460019

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, wound-nonadherentA sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Length13Centimeter
Width5Inch
Width13Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(610)530-3193BioMedCS@silon.com

Regulatory Flags#

DUNS number
364435974
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050460163Oleeva Foam 1.5x5320832082023-12-31
00810050460170Oleeva Foam 5x5322532252023-12-31
00810050460187Oleeva Foam 5x10325032502023-12-31
00810050460194Oleeva Foam 11x12329632962023-12-31
00810050460200Oleeva Foam Abdominoplasty Shape32APS32APS2023-12-31
00810050460217Oleeva Foam Breast Areola Shape32BA32BA2023-12-31
00810050460224Oleeva Foam 5.2x2.232BF32BF2023-12-31
00810050460231Oleeva Foam Breast Anchor Shape32BFS32BFS2023-12-31
00810050460248Oleeva Foam Breast Kit32BKS32BKS2023-12-31
00810050460255Oleeva Foam C-Section32CS32CS2023-12-31
00810050460262Oleeva Foam Vertical Mastopexy Shape32VM32VM2023-12-31
00810050460279Oleeva Clear 1.5x3350435042023-12-31
00810050460286Oleeva Clear 1.5x5350835082023-12-31
00810050460293Oleeva Clear 5x5352535252023-12-31
00810050460309Oleeva Clear 5x10355035502023-12-31
00810050460316Oleeva Clear 8x12359635962023-12-31
00810050460323Oleeva Fabric 1.5x3370437042023-12-31
00810050460378Oleeva Fabric 1.5x5370837082023-12-31
00810050460385Oleeva Fabric 1.5x7371037102023-12-31
00810050460392Oleeva Fabric 2x8371637162023-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30884389803114MEDLINEMEDLINE INDUSTRIES, INC.MGP2024-08-06
00810050460033Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460101Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
00810050460118Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
10810050460030Silon-TSR 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460108Dual-Dress 50 11x12Bio Med Sciences, Inc.MGP2023-12-31
10810050460115Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
00810050460026Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
00810050460040Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
00810050460057Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
10810050460016Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
10810050460023Silon-TSR 5x10Bio Med Sciences, Inc.MGP2023-08-04
10810050460047Silon-TSR Face Mask DesignBio Med Sciences, Inc.MGP2023-08-04
10810050460054Silon-TSR Face Mask KitBio Med Sciences, Inc.MGP2023-08-04
00050428287071CVS Health™WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMGP2022-09-24
M7528900120Stradis Medical, LLC.STRADIS MEDICAL, LLCMGP2022-06-01
M7528900030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528900031STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528910030STRADIS STRADIS MEDICAL, LLCMGP2022-05-17
M7528204040STRADIS STRADIS MEDICAL, LLCMGP2022-05-16
M7528900070STRADIS HEALTHCARESTRADIS MEDICAL, LLCMGP2022-03-31
00856525007365PFAB SMALLSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007372PFAB MediumSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007389PFAB Medium CrescentSUN SCIENTIFIC, INC.MGP2021-04-30
00856525007396PFAB LargeSUN SCIENTIFIC, INC.MGP2021-04-30
05000223449889"ACTICOAT 4""X48"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565121536ACTICOAT 4"X48"SMITH & NEPHEW MEDICAL LIMITEDMGP2020-09-18
00040565122045"ACTICOAT 3 5"" X 5"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16
05000223449766"ACTICOAT 4"" X 4"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16
05000223449797"ACTICOAT 4"" X 8"""SMITH & NEPHEW MEDICAL LIMITEDMGP2020-07-16