FDA.reportPublic FDA data

Rylon-1 5x10

Primary DI
10810050460085
Brand
Rylon-1 5x10
Company
Bio Med Sciences, Inc.
Model
2350.1
Catalog number
2350.1
Device description
Single-Sided Non-Adherent 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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050460085PackageGS110In Commercial Distribution
00810050460088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005046008510810050460085
00810050460088008100504600888100504600880810050460088

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Inch
Length25Centimeter
Width5Inch
Width13Centimeter

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
true
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

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Primary DI, Brand, Company table
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