Needle holder

GUDID 04059082021034

SOPRO-COMEG GmbH

Needle holder, reusable

• Primary Device ID: 04059082021034
• NIH Device Record Key: df7fdb64-ab92-4d55-8b4d-217ee3a63dba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle holder
• Version Model Number: 393 550 147
• 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	04059082021034 [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

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

Moist Heat or Steam Sterilization

[04059082021034]

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