FDA.reportPublic FDA data

Albahealth

Primary DI
00073614702554
Brand
Albahealth
Company
Albahealth, LLC
Model
0N5508009990902
Device description
"8"" x 48"" IMPERVIOUS NON-STER"
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792357000STERILE IMPERVIOUS ORTHOPEDIC STOCKINAlba-Waldensian, Inc.1979-12-18KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50073614702559PackageGS170In Commercial Distribution
00073614702554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5007361470255950073614702559
00073614702554000736147025540736147025540073614702554

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
003375805
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073614702226AlbahealthCN50120099909022016-09-22
00073614702271Albahealth0N54080099909022016-09-22
00073614702356AlbahealthCN54120099909022016-09-22
00073614702462Albahealth0N55060099909022016-09-22
00073614702509Albahealth0N55070099909022016-09-22
00073614702615AlbahealthCN55090099909022016-09-22
00073614702691AlbahealthCN55120099909022019-03-01
00073614702738Albahealth0N55180099909022016-09-22
00073614702790Albahealth0N55300099909022016-09-22
00073614702851AlbahealthCN55360099909022019-03-01
00073614702899Albahealth0N55640099909022016-09-22
00073614706149Albahealth0T50120099909022016-09-22
00073614706163AlbahealthCT54120099909022016-09-22
00073614706200Albahealth0T55090099909022016-09-22
00073614706224Albahealth0T55120099909022016-09-22
00073614709447AlbahealthC010480099903042016-09-22
00073614710924AlbahealthC206300099903042019-03-01
00073614710948AlbahealthC208380099903042016-09-22
00073614710979AlbahealthC210480099903042016-09-22
00073614726109Albahealth0M51080099909022016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
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10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29