FDA.reportPublic FDA data

Dual-Dress 50 11x12

Primary DI
10810050460108
Brand
Dual-Dress 50 11x12
Company
Bio Med Sciences, Inc.
Model
2932
Catalog number
2932
Device description
Foam Wound Dressing
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K990042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990042000SILON DUAL-DRESSBio Med Sciences, Inc.1999-03-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050460108PackageGS110In Commercial Distribution
00810050460101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005046010810810050460108
00810050460101008100504601018100504601010810050460101

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Inch
Length30Centimeter
Width11Inch
Width28Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
364435974
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
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
10810050460115Dual-Dress 50 11x24Bio Med Sciences, Inc.MGP2023-12-31
00810050460019Silon-TSR 5x5Bio Med Sciences, Inc.MGP2023-08-04
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