FDA.reportPublic FDA data

XLR8 Transparent Film Dressing

Primary DI
00849405002666
Brand
XLR8 Transparent Film Dressing
Company
GENADYNE BIOTECHNOLOGIES INC.
Model
A4-S00F5-UNS
Catalog number
A4-S00F5-UNS
Device description
Unsterile Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.
Published
2025-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143726000XLR8 PLUS (XLR8+)Genadyne Biotechnologies, Inc.2015-06-19OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849405002663PackageGS110In Commercial Distribution
00849405002666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084940500266310849405002663
00849405002666008494050026668494050026660849405002666

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system drapeA sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
006616130
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849405002796Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
10849405002793Hybrid Dressing - Revo UnsterileHFD-D1040-UNS2026-03-16
10849405002809Hybrid Dressing - Revo UnsterileHFD-D1050-UNS2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileHFD-D1030-UNS2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileHFD-D1530-UNS2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileHFD-D1520-UNS2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileHFD-D1020-UNS2026-03-16
00849405002581Genadyne DUO NPWTA7-S00012026-03-09
00849405024101XLR8 Abdominal Wound Dressing Kit A4-ABDO1-K2026-03-09
00849405002659XLR8/XLR8+ Port - UnsterileXP-1013-UNSXP-1013-UNS2025-12-03
00849405002673Hybrid Dressing - RevoHFD-D1020HFD-D10202026-01-12
00849405002680Hybrid Dressing - RevoHFD-D1520HFD-D15202026-01-12
00849405002697Hybrid Dressing - RevoHFD-D1030HFD-D10302026-01-12
00849405002703Hybrid Dressing - RevoHFD-D1530HFD-D15302026-01-12
00849405002710Hybrid Dressing - RevoHFD-D1040HFD-D10402026-01-12

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Primary DI, Brand, Company table
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00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
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