FDA.reportPublic FDA data

UNBRANDED

Primary DI
00848340009709
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
KP50LNS
Device description
Snap Kap
Published
2016-09-28
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
JAASystem, x-ray, fluoroscopic, image-intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340009706PackageGS1100In Commercial Distribution
00848340009709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000970610848340009706
00848340009709008483400097098483400097090848340009709

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. 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
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00848340002366Doppler Flow Wire CoverDFC1012024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00643169618121O-armMEDTRONIC NAVIGATION, INC.JAA2024-10-10
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-10-09
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195278719720AlliaGE MEDICAL SYSTEMSJAA2023-12-08
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08800018420904EXTRON 7DRTECH CorporationJAA2023-08-24
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000409Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195451000416Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
00195278524904OptimaGE Hualun Medical Systems Co., LtdJAA2022-10-20