Nunc IVF ICSI Dish

GUDID 00866630000427

IVF ICSI DISH

Nalge Nunc International Corporation

Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish

• Primary Device ID: 00866630000427
• NIH Device Record Key: fd80aed5-4d15-47b0-9b5f-6d4b785ff367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nunc IVF ICSI Dish
• Version Model Number: 150265
• Company DUNS: 080844844
• Company Name: Nalge Nunc International Corporation
• Device Count: 3
• 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: false
• 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	00866630000410 [Primary]
GS1	00866630000427 [Package]; Contains: 00866630000410; Package: Case [120 Units]; In Commercial Distribution
GS1	80866630000416 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090429

FDA Product Code

• MQK: LABWARE, ASSISTED REPRODUCTION

Sterilization

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

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

[00866630000427]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-09-09

Devices Manufactured by Nalge Nunc International Corporation

• 30850016060458 - Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap: 2022-09-12 90ML/48MM SPCW/LBL, WH CAP, ST
• 30850016060465 - Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box: 2022-09-12 90ML/48 SPCWLB,ORCAP,DSPNSR,ST
• 30850016060472 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap: 2022-09-12 90ML/53MM SPC W/LBL, WH CAP,ST
• 30850016060489 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap: 2022-09-12 90ML/53MM SPCW/LBL, NTL CAP,ST
• 30850016060496 - Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap: 2022-09-12 90ML/53MM SPC W/LBL, OR CP, ST
• 30850016060502 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap: 2022-09-12 60ML/48MMSPCW/LBL, OR CAP, ST
• 30850016060519 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap: 2022-09-12 60ML/48MMSPCW/LBL, WH CAP, ST
• 30850016060526 - Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap: 2022-09-12 60ML/48MMSPCW/LBL, GRN CAP, ST