SLM

GUDID 30816633023139

Blastomere Biopsy Pipette

SUNLIGHT MEDICAL, INC.

Mechanical pipette

• Primary Device ID: 30816633023139
• NIH Device Record Key: ab4bfc26-d719-4809-9b21-dba2c51ae80b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLM
• Version Model Number: SBB-25X-30
• Company DUNS: 039709088
• Company Name: SUNLIGHT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from sunlight, Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816633023135 [Primary]
GS1	30816633023139 [Package]; Contains: 10816633023135; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092554

FDA Product Code

• PUC: Microtools, Assisted Reproduction (Pipettes), Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [SLM]

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