FDA.reportPublic FDA data

Abena

Primary DI
00190509001391
Brand
Abena
Company
Abena North America, Inc
Model
1969
Device description
Silicone Foam Dressing with Film Backing
Published
2020-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190509000899PackageGS110Not in Commercial Distribution
00190509001148PackageGS110Not in Commercial Distribution
00190509001391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190509000899001905090008991905090008990190509000899
00190509001148001905090011481905090011480190509001148
00190509001391001905090013911905090013910190509001391

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.

Regulatory Flags#

DUNS number
078740398
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713571001103Abena10000213342023-06-12
05713571010792Abena10000310562026-03-30
05713571010815Abena10000310572026-03-30
05703538498732Abena10000251072026-02-18
05703538498794Abena10000251102026-02-18
05703538498855Abena10000251132026-02-18
05703538498879Abena10000251142026-02-18
05703538498749Abena10000251072026-02-18
05703538498800Abena10000251102026-02-18
05703538498862Abena10000251132026-02-18
05703538498886Abena10000251142026-02-18
05703538382246Abena171622020-03-05
05703538330254Abena92562020-03-05
05703538357176Abena15562020-03-05
00190509001032Abena19572020-04-02
00190509001049Abena19582020-04-02
00190509001056Abena19592020-04-02
00190509001315Abena19602020-05-29
00190509001322Abena19612020-05-29
00190509001339Abena19622020-05-29

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Primary DI, Brand, Company table
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00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
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10840330701621ProCureTwin Med, LLCNAD2026-04-28
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10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
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10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
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