ICSI Pipette

GUDID 10805360016459

VITROLIFE INC.

User-induced micropipette
Primary Device ID10805360016459
NIH Device Record Key5d89e546-b503-43d2-990d-3e6896c36e91
Commercial Distribution StatusIn Commercial Distribution
Brand NameICSI Pipette
Version Model Number15358
Company DUNS051915038
Company NameVITROLIFE INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100805360016452 [Unit of Use]
GS110805360016459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQHMicrotools, Assisted Reproduction (Pipettes)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-21
Device Publish Date2018-04-20

On-Brand Devices [ICSI Pipette]

1080536001894115427
1080536001893415426
1080536001890315425
1080536001881115678
1080536001880415677
1080536001869915666
1080536001868215665
1080536001858315655
1080536001857615654
1080536001856915653
1080536001852115648
1080536001798215420
1080536001794415418
1080536001791315416
1080536001788315414
1080536001787615413
1080536001780715613
1080536001779115410
1080536001778415612
1080536001776015405
1080536001774615403
1080536001773915402
1080536001772215401
1080536001771515611
1080536001767815441
1080536001765415356
1080536001762315354
1080536001758615353
1080536001757915352
1080536001756215351
1080536001755515350
1080536001754815349
1080536001747015347
1080536001744915344
1080536001743215342
1080536001739515339
1080536001728915529
1080536001725815528
1080536001704315440
1080536001703615439
1080536001698515445
1080536001696115438
1080536001694715436
1080536001692315435
1080536001690915434
1080536001687915432
1080536001645915358
1080536001617615431
1080536001615215407
1080536001604615429

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