SLM

GUDID 30816633023610

Polar Body Biopsy Pipette

SUNLIGHT MEDICAL, INC.

Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette Mechanical pipette
Primary Device ID30816633023610
NIH Device Record Key2a83d903-cda7-475d-bb8c-8a4790255a76
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLM
Version Model NumberSPB-15S-30L
Company DUNS039709088
Company NameSUNLIGHT MEDICAL, INC.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS110816633023616 [Primary]
GS130816633023610 [Package]
Contains: 10816633023616
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PUCMicrotools, Assisted Reproduction (Pipettes), Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-04
Device Publish Date2024-03-27

On-Brand Devices [SLM]

30816633024365Denuding Pipettes
30816633024358Zona Drilling Pipette
30816633023498Blastomere Biopsy Pipette
30816633023481Blastomere Biopsy Pipette
30816633023474Polar Body Biopsy Pipette
30816633023467Blastomere Biopsy Pipette
30816633023450Blastomere Biopsy Pipette
30816633023443Blastomere Biopsy Pipette
30816633022484Holding Pipette
30816633022477Holding Pipette
30816633022460Holding Pipette
30816633022453Holding Pipette
30816633022446Holding Pipette
30816633022439Holding Pipette
30816633022422Holding Pipette
30816633021944ICSI Injection Pipette
30816633021937ICSI Injection Pipette
30816633021920ICSI Injection Pipette
30816633021913ICSI Injection Pipette
30816633021906ICSI Injection Pipette
30816633021890ICSI Injection Pipette
30816633021883ICSI Injection Pipette
10816633024347Zona Drilling Pipette
30816633024334Denuding Pipettes
30816633024327Zona Drilling Pipette
30816633024310Denuding Pipettes
30816633024303Denuding Pipettes
30816633024297Denuding Pipettes
30816633024280Denuding Pipettes
30816633024273Denuding Pipettes
30816633024266Denuding Pipettes
30816633024259Denuding Pipettes
30816633024242Denuding Pipettes
30816633024235Denuding Pipettes
30816633024228Denuding Pipettes
30816633024211Denuding Pipettes
30816633024204Denuding Pipettes
30816633024198Denuding Pipettes
30816633024181Denuding Pipettes
30816633024174Denuding Pipettes
30816633024167Denuding Pipettes
30816633024150Denuding Pipettes
30816633024143Denuding Pipettes
30816633024136Denuding Pipettes
30816633024129Denuding Pipettes
30816633024112Denuding Pipettes
30816633024105Denuding Pipettes
30816633024099Denuding Pipettes
30816633024082Denuding Pipettes
30816633024075PZD Pipette

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