BIGopsy BLB-024115
GUDID 10827002482408
BIGopsy Backloading Biopsy Forceps
COOK IRELAND LTD
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 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| 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 |
Devices Manufactured by COOK IRELAND LTD
| 00827002597426 - Echotip ClearCore | 2025-01-28 Echotip ClearCore EUS Biopsy Needle |
| 00827002609921 - EchoTip ClearCore | 2025-01-22 Echotip ClearCore EUS Biopsy Needle |
| 00827002597464 - EchoTip AcuCore | 2023-10-11 EchoTip AcuCore EUS Biopsy Needle |
| 10827002306513 - COOK | 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH |
| 10827002306520 - COOK | 2023-02-24 DISPOSABLE ENDOSCOPIC CLEANING BRUSH |
| 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 |
Trademark Results [BIGopsy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIGOPSY 77042332 3406087 Live/Registered |
Cook Medical Technologies LLC 2006-11-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.