SFG ICSI pipettes

GUDID 00850068289158

SPECTRUM FERTILITY GROUP INC.

User-induced micropipette

• Primary Device ID: 00850068289158
• NIH Device Record Key: 19b906b1-0b98-4b77-806a-b80aa76e0259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFG ICSI pipettes
• Version Model Number: S-P-I40.35
• Company DUNS: 119292307
• Company Name: SPECTRUM FERTILITY GROUP INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068289158 [Unit of Use]
GS1	10850068289155 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [SFG ICSI pipettes]

• 00850068289172: S-P-I50.35
• 00850068289165: S-P-I45.35
• 00850068289158: S-P-I40.35
• 00850068289141: S-P-I50.30
• 00850068289134: S-P-I45.30
• 00850068289127: S-P-I40.30