FDA.reportPublic FDA data

Aortotomy System Lancet 3.3mm

Primary DI
20634624175338
Brand
Aortotomy System Lancet 3.3mm
Company
QUEST MEDICAL INC
Model
ALX33
Published
2019-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624175338PackageGS125In Commercial Distribution
00634624175334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462417533820634624175338
00634624175334006346241753346346241753340634624175334

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useA sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041810693
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10634624100616Tie-V Securement DeviceQIVB00602022-12-15
00634624417021Lyka® PORT Needle Free Access Device4170Y2025-06-12
20634624533039Vessel Cannula, 3mmVCC-03VCC-032016-06-07
00634624031500Q2® Needleless injection site 315031502017-03-09
20634624100606Qlinch Securement BandQSB00602020-04-08
20634624530380MPS 3 ISO Medical Air Hose Kit5303010-CA2023-10-16
00634624096523Checkmate IV Administration Set 123in (312 cm)965296522016-07-29
20634624530397MPS 3 Drug Pump Cover53030312023-03-24
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624911048High-Flow Extension SetHF01352022-12-12
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

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Primary DI, Brand, Company table
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00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040043SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
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00846159040074SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
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00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039863SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWS2026-05-27
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