| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002482408 [Primary] |
| FCL | FORCEPS, BIOPSY, NON-ELECTRIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-20 |
| Device Publish Date | 2023-02-10 |
| 10827002256702 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256719 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256726 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256733 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256740 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256757 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256764 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
| 10827002256856 - Solus | 2025-12-22 Solus, Double Pigtail Stent with Introducer |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIGOPSY 77042332 3406087 Live/Registered |
Cook Medical Technologies LLC 2006-11-13 |