FDA.reportPublic FDA data

Tulip GEMS™ AlphaLuer Single-Use

Primary DI
00819127023331
Brand
Tulip GEMS™ AlphaLuer Single-Use
Company
Tulip Medical Products
Model
DCALMIL1415-10
Device description
Single-Use AlphaLuer Miller Harvester Cannula, 2.1mm x 15cm, Set of 10
Published
2025-02-03
Public version status
New
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
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819127023331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819127023331008191270233318191270233310819127023331

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, single-useA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113564152
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819127022242Tulip GEMS™ Single-UseDATLLLL1.2mm-012025-02-05
00819127022273Tulip GEMS™ Single-UseDATLLLL1.2mm-102025-02-05
00819127022693Tulip GEMS™ Single-UseDMICRO-052025-02-05
00819127022808Tulip GEMS™ Single-UseDPK-SFB-TNF-012025-02-05
00819127022846Tulip GEMS™ Single-UseDNTS-1P2025-02-05
00819127022853Tulip GEMS™ Single-UseDNTS-5P2025-02-05
00819127023928Tulip GEMS™ Single-UseDMICRO-012025-02-05
00819127022259Tulip GEMS™ Single-UseDATLLLL1.4mm-012025-02-04
00819127022266Tulip GEMS™ Single-UseDATLLLL2.4mm-012025-02-04
00819127022280Tulip GEMS™ Single-UseDATLLLL1.4mm-102025-02-04
00819127022297Tulip GEMS™ Single-UseDATLLLL2.4mm-102025-02-04
00819127022495Tulip GEMS™ Single-UseDJS220-012025-02-04
00819127022501Tulip GEMS™ Single-UseDMS160G2-012025-02-04
00819127022518Tulip GEMS™ Single-UseDJS360G2-012025-02-04
00819127022525Tulip GEMS™ Single-UseDJS360G2-05 2025-02-04
00819127022723Tulip GEMS™ Single-UseDNFT90G2-012025-02-04
00819127022730Tulip GEMS™ Single-UseDNFT90G2-052025-02-04
10819127022492Tulip GEMS™ Single-UseDJS220-052025-02-04
10819127022508Tulip GEMS™ Single-UseDMS160G2-052025-02-04
00819127020705Tulip GEMS™ Single-Use DNTC-012025-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30
04260170880949WAL CannulaHuman Med AGQPB2025-07-30
04260170880963WAL CannulaHuman Med AGQPB2025-07-30
04260170881007Biofill CannulaHuman Med AGQPB2025-07-30
04260170881021Biofill Infiltration CannulaHuman Med AGQPB2025-07-30