| Primary Device ID | 00846159027815 |
| NIH Device Record Key | 3e827971-c19f-44c0-b343-4fd4b4ebe568 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scanlan® SURG-I-LOOP® PLUS with blunt needle |
| Version Model Number | 1001-81PB |
| Catalog Number | 1001-81PB |
| Company DUNS | 023055619 |
| Company Name | SCANLAN INTERNATIONAL INC |
| 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 | 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 |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846159027815 [Primary] |
| GAE | Snare, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846159027815]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-12-14 |
| 00846159027815 | Scanlan® SURG-I-LOOP® PLUS with blunt needle - Light Green, 37cm long, needle 1mm diam, Bulk N |
| 00846159001075 | Scanlan® SURG-I-LOOP® PLUS with blunt needle - Light Green, 37cm long, needle 1mm diam (2/pkg) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SCANLAN 74389302 1837794 Live/Registered |
Scanlan International, Inc. 1993-05-07 |
![]() SCANLAN 73625084 1439873 Live/Registered |
SCANLAN INTERNATIONAL, INC. 1986-10-14 |