ETHICON SECURESTRAP OPSTRAP20

GUDID 30705031231058

Absorbable Strap Fixation Device

ETHICON, LLC

Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use Open-surgery manual linear stapler, single-use

• Primary Device ID: 30705031231058
• NIH Device Record Key: cb4003b9-82d0-427b-8077-4f55c8f25411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETHICON SECURESTRAP
• Version Model Number: OPSTRAP20
• Catalog Number: OPSTRAP20
• Company DUNS: 079402290
• Company Name: ETHICON, LLC
• 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

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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• Phone: +1(877)384-4266
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031231054 [Primary]
GS1	30705031231058 [Package]; Contains: 10705031231054; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123114

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-05
• Device Publish Date: 2015-09-23

On-Brand Devices [ETHICON SECURESTRAP]

• 30705031202744: Absorbable Strap Fixation Device
• 30705031231058: Absorbable Strap Fixation Device
• 30705031132973: Absorbable Strap Fixation Device
• 30705031132980: Absorbable Strap Fixation Device
• 10705031470552: ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE
• 10705031470569: ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE
• 10705031470576: ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE