Needle holder

GUDID 04059082021041

SOPRO-COMEG GmbH

Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable

• Primary Device ID: 04059082021041
• NIH Device Record Key: 831d8223-aee3-45cb-ba1b-22ba0072eb80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle holder
• Version Model Number: 393 550 148
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04059082021041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

[04059082021041]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Needle holder]

• 04059082025247: 394 560 049
• 04059082025230: 394 560 048
• 04059082025223: 394 560 047
• 04059082025216: 394 560 046
• 04059082025193: 394 550 049
• 04059082025186: 394 550 048
• 04059082025179: 394 550 047
• 04059082025162: 394 550 046
• 04059082025155: 394 540 049
• 04059082025148: 394 540 048
• 04059082025131: 394 540 047
• 04059082025124: 394 540 046
• 04059082021195: 393 560 149
• 04059082021188: 393 560 148
• 04059082021171: 393 560 147
• 04059082021164: 393 560 146
• 04059082021089: 393 560 047
• 04059082021072: 393 560 046
• 04059082021058: 393 550 149
• 04059082021041: 393 550 148
• 04059082021034: 393 550 147
• 04059082021027: 393 550 146
• 04059082021010: 393 550 049
• 04059082021003: 393 550 048
• 04059082020990: 393 550 047
• 04059082020983: 393 550 046
• 04059082020976: 393 540 149
• 04059082020969: 393 540 148
• 04059082020952: 393 540 147
• 04059082020945: 393 540 146
• 04059082020938: 393 540 049
• 04059082020921: 393 540 048
• 04059082020914: 393 540 047
• 04059082020907: 393 540 046
• 04059082014500: 392 992 011
• 04059082014494: 392 992 001