SFG Denuding pipettes

GUDID 00850068289011

SPECTRUM FERTILITY GROUP INC.

User-induced micropipette

• Primary Device ID: 00850068289011
• NIH Device Record Key: b82b2827-8688-4e2e-8f48-0571d79f5876
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFG Denuding pipettes
• Version Model Number: S-P-D140
• 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	00850068289011 [Unit of Use]
GS1	10850068289018 [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 Denuding pipettes]

• 00850068289110: S-P-D290
• 00850068289103: S-P-D270
• 00850068289097: S-P-D250
• 00850068289080: S-P-D230
• 00850068289073: S-P-D210
• 00850068289066: S-P-D190
• 00850068289059: S-P-D180
• 00850068289042: S-P-D170
• 00850068289035: S-P-D160
• 00850068289028: S-P-D150
• 00850068289011: S-P-D140
• 00850068289004: S-P-D130