SCANLAN® Minimally Invasive Instrumentation 9009-550
GUDID 00846159024197
Thoracoscopic Axial Needle Holder, (7mm), (for 5-0 and smaller needles), round handle, axial design, straight Diamond Dust™ jaws, without ratchet, 20 cm working length, 14-3/8”/36.5 cm total length
SCANLAN INTERNATIONAL INC
Needle holder, reusable| Primary Device ID | 00846159024197 |
| NIH Device Record Key | ee04b7f4-8fbb-4238-97dd-be953a5efc57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCANLAN® Minimally Invasive Instrumentation |
| Version Model Number | 9009-550 |
| Catalog Number | 9009-550 |
| Company DUNS | 023055619 |
| Company Name | SCANLAN INTERNATIONAL INC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com | |
| Phone | 651-298-0997 |
| vanderpoelw@scanlangroup.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846159024197 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K945474
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
[00846159024197]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-13 |
| Device Publish Date | 2019-12-05 |
On-Brand Devices [SCANLAN® Minimally Invasive Instrumentation]
| 00846159032307 | Thoracoscopic Rocco Nodule Clamp, 5.2CM 13 1/4" Copy |
| 00846159032291 | Thoracoscopic Rocco Nodule Clamp, 3.7CM 13 1/4" |
| 00846159032215 | Thoracoscopic Cassivi Clamp |
| 00846159032208 | Thoracoscopic Cassivi Clamp |
| 00846159032178 | Thoracoscopic Dennis Clamp |
| 00846159032161 | Thoracoscopic Dennis Clamp |
| 00846159032154 | Thoracoscopic Duval Clamp |
| 00846159032147 | Thoracoscopic Duval Clamp |
| 00846159029260 | Thoracoscopic Decortication Clamp 13 1/4" |
| 00846159008654 | SCANLAN® Thoracoscopic Foerster Clamp |
| 00846159024302 | Thoracoscopic Axial Needle Holder, (7mm), (for 2-0 and smaller needles), gold-tipped round handl |
| 00846159024296 | Thoracoscopic Axial Needle Holder, (7mm), (for 2-0 and smaller needles), gold-tipped round handl |
| 00846159024289 | Thoracoscopic Axial Needle Holder, (7mm), (for 2-0 and smaller needles), gold-tipped round handl |
| 00846159024272 | Thoracoscopic Axial Needle Holder, (7mm), (for 2-0 and smaller needles), gold-tipped round handl |
| 00846159024265 | Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handl |
| 00846159024258 | Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handl |
| 00846159024241 | Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handl |
| 00846159024234 | Thoracoscopic Axial Needle Holder, (7mm), (for 4-0 and smaller needles), gold-tipped round handl |
| 00846159024227 | Thoracoscopic Axial Needle Holder, (7mm), (for 5-0 and smaller needles), round handle, axial des |
| 00846159024210 | Thoracoscopic Axial Needle Holder, (7mm), (for 5-0 and smaller needles), round handle, axial des |
| 00846159024203 | Thoracoscopic Axial Needle Holder, (7mm), (for 5-0 and smaller needles), round handle, axial des |
| 00846159024197 | Thoracoscopic Axial Needle Holder, (7mm), (for 5-0 and smaller needles), round handle, axial des |
| 00846159024180 | Thoracoscopic Axial Needle Holder, (7mm), (for 7-0 and smaller needles), round handle, axial des |
| 00846159024173 | Thoracoscopic Axial Needle Holder, (7mm), (for 7-0 and smaller needles), round handle, axial des |
| 00846159024166 | Thoracoscopic Axial Needle Holder, (7mm), (for 7-0 and smaller needles), round handle, axial des |
| 00846159024159 | Thoracoscopic Axial Needle Holder, (7mm), (for 7-0 and smaller needles), round handle, axial des |
| 00846159021288 | SCANLAN® CardioVasive™ /Thoracoscopic Fine Needle Holder (5 mm), Ring Handle, Curved Diamond |
| 00846159021271 | SCANLAN® CardioVasive™ /Thoracoscopic Fine Needle Holder (5 mm), Ring Handle, `Diamond Dust |
| 00846159035230 | SCANLAN® Thoracoscopic Chitwood Suture Cutter 15cm, 10" working length |
| 00846159035384 | SCANLAN® Thoracoscopic Foerster Clamp 10mm |
| 00846159021578 | THORACOSCOPIC FOERSTER CLAMP (10MM) 20MM OVAL RING JAW W/O RAT 13-1/4"/33.5 cm |
| 00846159021561 | THORACOSCOPIC JACOBSON DEBAKEY FORCEPS (10MM) 2MM JAW 16 1/2" / 42CM |
| 00846159021530 | CardioVasive™ Thoracoscopic DeBakey Clamp, 10mm, Curved left, 2 x 3 wide jaw (10 cm jaw length |
| 00846159035407 | SCANLAN® Thoracoscopic DeBakey Clamp |
| 00846159013603 | SCANLAN® Thoracoscopic Clamp |
| 00846159008678 | SCANLAN® Thoracoscopic Clamp |
| 00846159014532 | SCANLAN® Dennis Suction Instrument Knurled Blunt Tip |
Trademark Results [SCANLAN]
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 |
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