SFG Holding pipettes

GUDID 00850068289226

SPECTRUM FERTILITY GROUP INC.

User-induced micropipette

• Primary Device ID: 00850068289226
• NIH Device Record Key: 296490d6-3e71-4cc4-9223-415f2051967c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFG Holding pipettes
• Version Model Number: S-P-H100M.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	00850068289226 [Unit of Use]
GS1	10850068289223 [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 Holding pipettes]

• 00850068289257: S-P-H140L.35
• 00850068289240: S-P-H120L.35
• 00850068289233: S-P-H120M.35
• 00850068289226: S-P-H100M.35
• 00850068289219: S-P-H140L.30
• 00850068289202: S-P-H120L.30
• 00850068289196: S-P-H120M.30
• 00850068289189: S-P-H100M.30