SFG Biopsy pipettes

GUDID 00850068289424

SPECTRUM FERTILITY GROUP INC.

User-induced micropipette

• Primary Device ID: 00850068289424
• NIH Device Record Key: 54c106df-f3c5-4d2d-936c-2b8db8f17d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFG Biopsy pipettes
• Version Model Number: S-P-B35.35
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068289424 [Unit of Use]
GS1	10850068289421 [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 Biopsy pipettes]

• 00850068289431: S-P-B40.35
• 00850068289424: S-P-B35.35
• 00850068289417: S-P-B30.35
• 00850068289400: S-P-B25.35
• 00850068289394: S-P-B20.35
• 00850068289387: S-P-B40.30
• 00850068289370: S-P-B35.30
• 00850068289363: S-P-B30.30
• 00850068289356: S-P-B25.30
• 00850068289349: S-P-B20.30