FDA.reportPublic FDA data

Soft Flex Probe Cover

Primary DI
00848340019517
Brand
Soft Flex Probe Cover
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
20-PC524
Device description
Disposable Probe Cover
Published
2023-06-13
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
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011265000ULTRASOUND TRANSDUCER COVERAdvance Medical Designs, Inc.2001-10-30ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340019514PackageGS125In Commercial Distribution
00848340019517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834001951410848340019514
00848340019517008483400195178483400195170848340019517

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848340021879Mitaka DrapeMU90902026-06-25
00848340018213Urological Drainage BagKTEK84112026-05-07
00848340018220Urological Drainage BagKYRA84102026-04-15
00848340018206Urological Drainage BagKTEK84102026-04-13
00848340010712C-FlexA-707022026-03-12
10848340010719C-FlexA-707022026-03-12
00848340014857Asonic GelASG-0012023-06-13
00848340002212Transducer Cover05-TC9962024-02-05
00848340002229Custom Cover08-CC1242024-02-06
00848340002236Custom Cover08-CC1342024-02-07
00848340002243Custom Cover08-CC1372024-02-07
00848340002250Custom Cover08-CC1392024-02-08
00848340002267Custom Cover08-CC1402024-02-08
00848340002281Camera Cover08-CC1492024-02-12
00848340002298Cassette Drape08-CC1502024-02-15
00848340002311Snap Kover08-CC1622024-02-15
00848340002328Custom Pack08-CC1632024-02-15
00848340002335Custom Pack08-CC1702024-02-20
00848340002342Positioning Arm Drape08-CU15612024-02-21
00848340002359Doppler Flow Wire CoverDFC1002024-03-13

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00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
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