TruFire™ 382200cn

GUDID 10810128460603

TruFire™ Suture Passer Needle

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Suturing needle, single-use

• Primary Device ID: 10810128460603
• NIH Device Record Key: 8a90c228-b3bf-4d54-a4f4-7c1520b6b147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruFire™
• Version Model Number: TF-N
• Catalog Number: 382200cn
• Company DUNS: 534123013
• Company Name: T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
• Device Count: 5
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810128460603 [Unit of Use]
GS1	30810128460607 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

[10810128460603]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-06
• Device Publish Date: 2024-10-29

On-Brand Devices [TruFire™ ]

• 10810128460603: TruFire™ Suture Passer Needle
• 10810128460627: TruFire™ Suture Passer with Ratcheting Handle
• 10810128460610: TruFire™ Suture Passer with Non-Ratcheting Handle