FDA.reportPublic FDA data

Inoculating Needle Rigid Typenex

Primary DI
06973267013141
Brand
Inoculating Needle Rigid Typenex
Company
ZHEJIANG RUNLAB TECHNOLOGY CO., LTD
Model
Rigid, Dark blue, LP0302
Device description
Rigid, Dark blue, LP0302
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973267013127PackageGS150Not in Commercial Distribution
06973267013134PackageGS120In Commercial Distribution
16973267013124PackageGS16Not in Commercial Distribution
06973267013141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973267013127069732670131276973267013127
06973267013134069732670131346973267013134
1697326701312416973267013124
06973267013141069732670131416973267013141

GMDN Terms#

Term, Definition table
TermDefinition
Specimen transfer scooping tool IVDA hand-held manual instrument intended to be used to scoop a clinical specimen or microbial isolate for transfer from a primary vessel to a secondary container (e.g., from a specimen collection receptacle to a reagent tube, or from a culture medium to a general laboratory test tube) for subsequent in vitro diagnostic analysis and/or other investigation. It is typically a slender device with a loop, rake, or ball at the distal end used to scoop and transfer the clinical specimen or microbial isolate. This is a single-use device.

Regulatory Flags#

DUNS number
529124298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TB1UL,RIGID,LP0102TBLP0102TB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TB1UL,FLEXIBLE,LP0103TBLP0103TB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TB10UL,RIGID,LP0202TBLP0202TB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TB10UL,FLEXIBLE,LP0203TBLP0203TB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBNEEDLE,RIGID,LP0302TBLP0302TB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TB1UL,RIGID,LP0102TBLP0102TB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TB1UL,FLEXIBLE,LP0103TBLP0103TB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TB10UL,RIGID,LP0202TBLP0202TB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TB10UL,FLEXIBLE,LP0203TBLP0203TB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBNEEDLE,RIGID,LP0302TBLP0302TB2025-07-17
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PF1ul,rigid,dark blue, LP0102PFLP0102PF2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PF1ul,flexible, blue, LP0103PFLP0103PF2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PF10ul,rigid,dark blue, LP0202PFLP0202PF2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PF10ul,flexible, blue, LP0203PFLP0203PF2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFRigid, Dark blue, LP0302PFLP0302PF2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PF1ul,rigid,dark blue, LP0102PFLP0102PF2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PF1ul,flexible, blue, LP0103PFLP0103PF2025-02-13
06973267012243Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PF10ul,rigid,dark blue, LP0202PFLP0202PF2025-02-13
06973267012250Inoculating Loop 10ul flexible Typenex LP0203PF10ul,flexible, blue, LP0203PFLP0203PF2025-02-13
06973267013233Inoculating Needle Rigid perforated bag packTypenex LP0302PFRigid, Dark blue, LP0302PFLP0302PF2025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344074369MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074376MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074383MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074390MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074362MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074379MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074386MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074393MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
05032384127993REAGENT SPOT INDOLE DMACAOXOID LIMITEDLIB2025-06-27
09555240404992SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
19555240404999SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
09555240405593SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
19555240405590SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13