Surgical Direct SD8353111
GUDID B382SD83531110
5mm 10' Autoclavable Fiber Optic Light Cable, Clear, Light Source Type: Wolf, Dyonics, and Stryker X8000, and L9000..Scope Type: Wolf and Dyonics, Large Clip On
Surgical Direct, Inc.
Fibreoptic light cable| Primary Device ID | B382SD83531110 |
| NIH Device Record Key | ea291d33-c8e2-49bc-864f-2550513d1599 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Direct |
| Version Model Number | SD8353111 |
| Catalog Number | SD8353111 |
| Company DUNS | 124367223 |
| Company Name | Surgical Direct, 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 | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com | |
| Phone | +1 (800) 519-3293 |
| info@surgicaldirect.com |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
| Length | 10 Feet |
| Outer Diameter | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B382SD83531110 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021931
FDA Product Code
| FFS | Image, Illumination, Fiberoptic, For Endoscope |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
[B382SD83531110]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-25 |
On-Brand Devices [Surgical Direct]
| B382SD984320 | 5mm 33cm Short Maryland Dissector, Cross Serrated, Insulated Non-Locking Handle, Flushport |
| B382SD984240 | 5mm 33cm 90° Right Angle Grasping Forcep, for 7mm Cannula or Larger, with On/Off D Handle |
| B382SD984230 | 5mm 33cm Endoclinch Grasper, Double Action, with Stainless Steel On/Off Ratchet |
| B382SD984220 | 5mm 33cm 90° Right Angle Grasping Forcep, with Non-Locking Handle |
| B382SD984030 | 5mm 33cm Stone Cup Grasper Serrated, Double Action with Insulated Stainless Steel Handle, On/Off |
| B382SD983950 | 5mm 33cm Tissue Grasper Serrated, Double Action with Insulated Non-Locking Handle |
| B382SD983940 | 5mm 33cm Tissue Grasper Serrated, Double Action with Insulated Stainless Steel Handle, On/Off D |
| B382SD983930 | 5mm 33cm Tissue Grasper Serrated, Double Action with Insulated Stainless Steel Handle, On/Off Ha |
| B382SD983830 | 5mm 33cm Single Modified Allis Grasper, Stainless Steel Insulated Handle with On/Off Ratchet |
| B382SD983740 | 5mm 33cm Sharp Tooth Grasper with Cup On/Off D Ratchet |
| B382SD983730 | 5mm 33cm Sharp Tooth Grasper with Cup, On/Off Ratchet |
| B382SD983620 | 5mm 33cm Cup Grasper, Serrated Edge, Insulated, Stainless Steel Handle, Flushport |
| B382SD983530 | 5mm 33cm Flat Blunt Dissector, Fenestrated, Stainless Steel, Insulated Handle with On/Off Ratche |
| B382SD983520 | 5mm 33cm Flat Blunt Dissector, Fenestrated, Original Non-Locking Handle |
| B382SD983510 | 5mm 33cm Flat Blunt Dissector, Fenestrated, Original Locking Handle |
| B382SD9834203 | 5mm 33cm Soft Curved Dissector, Serrated, with Stainless Steel Insulated Non-Locking Handle |
| B382SD983330 | 5mm 33cm Dolphin Nose Dissector, Serrated, without Scoop, On/Off Ratchet |
| B382SD983320 | 5mm 33cm Dolphin Nose Dissector, Double Action, without Scoop with Stainless Steel Non-Locking H |
| B382SD983230 | 5mm 33cm Right Angle Dissector, Serrated, On/Off Ratchet |
| B382SD983220 | 5mm 33cm Right Angle Dissector, Serrated, Non-Locking Handle, Flushport |
| B382SD983120 | 5mm 33cm Scissor, Straight, Insulated Non-Locking Handle, Flushport |
| B382SD982720 | 5mm 33cm Hook Scissors, Single Action, Insulated Stainless Steel Non-Locking Handle |
| B382SD982620 | 5mm 33cm Metzenbaum Scissors, Curved with Insulated Stainless Steel Non-Locking Handle |
| B382SD982540 | 5mm 33cm Biopsy Spoon Forceps with Teeth, Insulated On/Off Ratchet |
| B382SD982530 | 5mm 33cm Biopsy Spoon Forceps with Teeth, Insulated On/Off Ratchet |
| B382SD98252S0 | 5mm 33cm Biopsy Spoon forceps without Teeth, Stainless Steel Insulated Handle Non-Locking.. |
| B382SD982520 | 5mm 33cm Biopsy Spoon Forceps with Teeth, Insulated Non-Locking Handle |
| B382SD982430 | 5mm 33cm Biopsy Punch Forcep, with Teeth, Stainless Steel Handle, with On/Off Ratchet |
| B382SD982420 | 5mm 33cm Biopsy Punch Forcep, with Teeth, Non-Locking Stainless Steel Handle |
| B382SD982340 | 5mm 33cm Claw Extractor, 2x3 Teeth, Stainless Steel Handle, with On/Off D Ratchet |
| B382SD982330 | 5mm 33cm Claw Extractor, 2x3 Teeth, Stainless Steel Handle, with On/Off Ratchet |
| B382SD982230 | 5mm 33cm Retraction Forceps, Atraumatic inner with Teeth, Stainless Steel Handle, On/Off Ratchet |
| B382SD982140 | 5mm 33cm Cobra Forceps, Double Action, Cross Serrated, with Teeth, Stainless Steel Handle, On/Of |
| B382SD982130 | 5mm 33cm Cobra Forceps, Double Action, Cross Serrated, with Teeth, Stainless Steel Handle, On/Of |
| B382SD982050 | 5mm 33cm Babcock Grasper, Double Action, with Insulated Non-Locking Handle |
| B382SD982040 | 5mm 33cm Babcock Grasper, Double Action, Stainless Steel Handle, with On/Off D Handle Ratchet |
| B382SD982030 | 5mm 33cm Babcock Grasper, Double Action, Stainless Steel Handle, with On/Off Ratchet |
| B382SD982010 | 5mm 33cm Babcock Grasper, Double Action, with Original Locking Handle |
| B382SD981940 | 5mm 33cm Allis Grasper, Double Action, Stainless Steel Handle, with On/Off D Handle Ratchet |
| B382SD981930 | 5mm 33cm Allis Grasper, Double Action, Stainless Steel Handle, with On/Off Ratchet |
| B382SD981840 | 5mm 33cm Retrograde Grasper, Stainless Steel Handle, On/Off Ratchet, with Flushport |
| B382SD981830 | 5mm 33cm Retrograde Grasper, Stainless Steel Handle, On/Off Ratchet, with Flushport |
| B382SD981740 | 5mm 33cm Atraumatic Wave Grasper, Double Action, with On/Off D Handle |
| B382SD981730 | 5mm 33cm Atraumatic Wave Grasper, Double Action with On/Off Ratchet |
| B382SD981710 | 5mm 33cm Atraumatic Wave Grasper, Double Action, with Original Locking Handle |
| B382SD981640 | 5mm 33cm Fundus Tri-Max Grasping Forceps, Stainless Steel Handle, with On/Off D Handle Ratchet |
| B382SD981630 | 5mm 33cm Fundus Grasper, Stainless Steel, Insulated Handle, with On/Off Ratchet |
| B382SD981540 | 5mm 33cm Alligator Grasper, Double action, Stainless Steel D Handle, On/Off Ratchet, Flushport |
| B382SD981530 | 5mm 33cm Alligator Grasper, Double action, Stainless Steel Handle, On/Off Ratchet, Flushport |
| B382SD981510 | 5mm 33cm Alligator Grasper, Double action, Original Locking Handle, Flushport |
Trademark Results [Surgical Direct]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGICAL DIRECT 90881956 not registered Live/Pending |
Surgical Direct Inc. 2021-08-13 |
 SURGICAL DIRECT 78115703 2765737 Dead/Cancelled |
David, Murray James 2002-03-18 |
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