ICSI Pipette

GUDID 10805360016176

VITROLIFE INC.

Assisted reproduction microtool

• Primary Device ID: 10805360016176
• NIH Device Record Key: 44fb0240-44e9-4c98-9c9c-3c33f81d657c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICSI Pipette
• Version Model Number: 15431
• Company DUNS: 051915038
• Company Name: VITROLIFE INC.
• Device Count: 10
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00805360016179 [Unit of Use]
GS1	10805360016176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991104

FDA Product Code

• MQH: Microtools, Assisted Reproduction (Pipettes)

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: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [ICSI Pipette]

• 10805360018941: 15427
• 10805360018934: 15426
• 10805360018903: 15425
• 10805360018811: 15678
• 10805360018804: 15677
• 10805360018699: 15666
• 10805360018682: 15665
• 10805360018583: 15655
• 10805360018576: 15654
• 10805360018569: 15653
• 10805360018521: 15648
• 10805360017982: 15420
• 10805360017944: 15418
• 10805360017913: 15416
• 10805360017883: 15414
• 10805360017876: 15413
• 10805360017807: 15613
• 10805360017791: 15410
• 10805360017784: 15612
• 10805360017760: 15405
• 10805360017746: 15403
• 10805360017739: 15402
• 10805360017722: 15401
• 10805360017715: 15611
• 10805360017678: 15441
• 10805360017654: 15356
• 10805360017623: 15354
• 10805360017586: 15353
• 10805360017579: 15352
• 10805360017562: 15351
• 10805360017555: 15350
• 10805360017548: 15349
• 10805360017470: 15347
• 10805360017449: 15344
• 10805360017432: 15342
• 10805360017395: 15339
• 10805360017289: 15529
• 10805360017258: 15528
• 10805360017043: 15440
• 10805360017036: 15439
• 10805360016985: 15445
• 10805360016961: 15438
• 10805360016947: 15436
• 10805360016923: 15435
• 10805360016909: 15434
• 10805360016879: 15432
• 10805360016459: 15358
• 10805360016176: 15431
• 10805360016152: 15407
• 10805360016046: 15429