Biotex

GUDID 08800039003308

PURGO BIOLOGICS Inc.

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 08800039003308
• NIH Device Record Key: 2979ed0c-e85d-427c-8e3d-48ab7a7c6bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotex
• Version Model Number: BT501655
• 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	08800039003308 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-14
• Device Publish Date: 2020-04-06

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