BIGopsy BLB-024115

GUDID 10827002482408

BIGopsy Backloading Biopsy Forceps

COOK IRELAND LTD

Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use Flexible endoscopic biopsy forceps, single-use

• Primary Device ID: 10827002482408
• NIH Device Record Key: 0a35b14a-00c9-4aae-8628-fd75fed459c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIGopsy
• Version Model Number: G48240
• Catalog Number: BLB-024115
• Company DUNS: 988559035
• Company Name: COOK IRELAND LTD
• Device Count: 1
• 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

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry location, away from temperature extremes.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002482408 [Primary]

FDA Product Code

• FCL: FORCEPS, BIOPSY, NON-ELECTRIC

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: 2023-02-20
• Device Publish Date: 2023-02-10

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• 10827002307145 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002307152 - COOK: 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET
• 10827002482408 - BIGopsy: 2023-02-20BIGopsy Backloading Biopsy Forceps
• 10827002482408 - BIGopsy: 2023-02-20 BIGopsy Backloading Biopsy Forceps
• 10827002480305 - Evolution: 2022-11-28 EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED
• 10827002480312 - Evolution: 2022-11-28 EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED