Biotex

GUDID 08800039000376

PURGO BIOLOGICS Inc.

Polyolefin suture, monofilament

• Primary Device ID: 08800039000376
• NIH Device Record Key: 7e10c2e7-ae9e-49da-9e91-1cbd9d65442c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotex
• Version Model Number: BT3016
• Company DUNS: 687429456
• Company Name: PURGO BIOLOGICS Inc.
• Device Count: 1
• 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: true
• 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	08800039000376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180992

FDA Product Code

• NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2019-07-24

On-Brand Devices [Biotex]

• 08800039003308: BT501655
• 08800039003292: BT501355
• 08800039003285: BT401355
• 08800039003278: BT301955
• 08800039003261: BT301655
• 08800039000581: BT401655
• 08800039000574: BT401955
• 08800039000567: BTP4019
• 08800039000550: BTP401335
• 08800039000543: BTP301335
• 08800039000536: BTP4013
• 08800039000529: BTP3013
• 08800039000512: BT501335
• 08800039000505: BT401335
• 08800039000499: BT301335
• 08800039000482: BT501635
• 08800039000475: BT401635
• 08800039000468: BT301635
• 08800039000451: BT501935
• 08800039000444: BT401935
• 08800039000437: BT301935
• 08800039000420: BT5013
• 08800039000413: BT4013
• 08800039000406: BT3013
• 08800039000390: BT5016
• 08800039000383: BT4016
• 08800039000376: BT3016
• 08800039000369: BT5019
• 08800039000352: BT4019
• 08800039000345: BT3019