CODMAN® 826608
GUDID 10381780520344
Cranial Drill Bit 5.8mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Manual cranial rotary handpiece, single-use| Primary Device ID | 10381780520344 |
| NIH Device Record Key | 6d233c56-87b1-40f7-8d14-df6b3c70b620 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® |
| Version Model Number | 82-6608 |
| Catalog Number | 826608 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780520344 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K914479
FDA Product Code
| GWM | Device, monitoring, intracranial pressure |
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 | 2020-04-09 |
| Device Publish Date | 2020-04-01 |
On-Brand Devices [CODMAN®]
| 10381780530374 | Electrosurgical Circular Foot Pedal |
| 10381780520313 | CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 80cm Medium Closing Pressure 5-9cm H2O |
| 10381780520306 | CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 50cm Medium Closing Pressure 5-9cm H2O |
| 10381780520290 | CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 25cm Medium Closing Pressure 5-9cm H2O |
| 10381780520283 | CODMAN ACCU-FLO 1 CSF Reservoir 24mm 1 Barium Ventricular Catheter, 1 Connector, Straight Barium |
| 10381780520276 | CODMAN ACCU-FLO 1 CSF Reservoir 14mm 1 Barium Ventricular Catheter, 1 Connector, Straight Barium |
| 10381780532880 | Electrosurgical Generator |
| 10381780532873 | Electrosurgical Irrigator |
| 10381780532866 | Electrosurgical Foot Pedal |
| 00381780521788 | Integrated Bipolar Cord and Tubing Set Flying Leads, Rotary Pump, Bulk |
| 00381780521771 | Integrated Bipolar Cord and Tubing Set Flying Leads, Rotary Pump |
| 00381780521764 | Integrated Bipolar Cord and Tubing Set Flying Leads, Gravity Feed, Bulk |
| 00381780521757 | Integrated Bipolar Cord and Tubing Set Flying Leads, Gravity Feed |
| 00381780521740 | Integrated Bipolar Cord and Tubing Set Fixed Leads, Rotary Pump |
| 00381780521733 | Integrated Bipolar Cord and Tubing Set Fixed Leads, Gravity Feed |
| 00381780521412 | Peel-Away Catheter Introducer 14 FR. |
| 00381780521405 | Peel-Away Catheter Introducer 12.5 FR. |
| 00381780521399 | Peel-Away Catheter Introducer 9 Fr. |
| 10381780520351 | Cranial Drill Bit 2.7mm |
| 10381780520344 | Cranial Drill Bit 5.8mm |
| 10381780520337 | Cranial Hand Drill |
| 10381780519942 | Disposable Split Trocar |
| 10381780515708 | Right Angle Cranial Clip with Tabs |
| 10381780515500 | Disposable Catheter Passer 65cm |
| 10381780515494 | Disposable Catheter Passer 55cm |
| 10381780515487 | Disposable Catheter Passer 36cm |
| 00381780515138 | Surgical Strips 3 1/2 Inches x 6 Inches (89mm x 152mm) |
| 00381780515121 | Surgical Strips 3 Inches x 6 Inches (76mm x 152mm) |
| 00381780515114 | Surgical Strips 2 Inches x 6 Inches (51mm x 152mm) |
| 00381780515107 | Surgical Strips 1 1/2 Inches x 6 Inches (38mm x 152mm) |
| 00381780515091 | Surgical Strips 1 Inch x 6 Inches (25mm x 152mm) |
| 00381780515084 | Surgical Strips 3/4 Inch x 6 Inches (19mm x 152mm) |
| 00381780515077 | Surgical Strips 1/2 Inch x 6 Inches (13mm x 152mm) |
| 00381780515060 | Surgical Strips 1/4 Inch x 6 Inches (6mm x 152mm) |
| 00381780515053 | Surgical Strips 1/8 Inch x 6 Inches (3mm x 152mm) |
| 00381780515046 | Surgical Patties 3 Inches x 3 Inches (7.62cm x 7.62cm) |
| 00381780515039 | Surgical Patties 1 Inch x 3 Inches (2.54cm x 7.62cm) |
| 00381780515022 | Surgical Patties 1/2 Inch x 3 Inches (1.27cm x 7.62cm) |
| 00381780515015 | Surgical Patties 1/2 Inch x 2 Inches (1.27cm x 5.08cm) |
| 00381780515008 | Surgical Patties 1/2 Inch x 1 1/2 Inches (1.27cm x 3.81cm) |
| 00381780514995 | Surgical Patties 1 Inch x 1 Inch (2.54cm x 2.54cm) |
| 00381780514988 | Surgical Patties 1/2 Inch x 1 Inch (1.27cm x 2.54cm) |
| 00381780514971 | Surgical Patties 3/4 Inch x 3/4 Inch (1.91cm x 1.91cm) |
| 00381780514964 | Surgical Patties 1/2 Inch x 1/2 Inch (1.27cm x 1.27cm) |
| 00381780514957 | Surgical Patties 1/4 Inch x 1/4 Inch (0.64cm x 0.64cm) |
| 00381780514940 | Surgical Patties 1/4 Inch x 3 Inches (0.64cm x 7.62cm) |
| 00381780514933 | Surgical Patties 1/4 Inch x 1 1/2 Inches (0.64cm x 3.81cm) |
| 00381780514926 | Surgical Patties 5/16 Inch (0.79cm) Dia. |
| 10381780514879 | Disposable ICP Kit, Plastic, Pediatric CONTENTS: 1 ICP Plastic Screw, 1 Spacing Washer, 1 Handle |
| 10381780514831 | Disposable ICP Kit, Plastic, Adult CONTENTS: 1 ICP Screw, 2 Spacing Washers, 1 Handle 1 Retracto |
Trademark Results [CODMAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN 72381672 0917323 Live/Registered |
JOHNSON & JOHNSON 1971-02-18 |
 CODMAN 72381347 0925169 Live/Registered |
JOHNSON & JOHNSON 1971-02-11 |
 CODMAN 72258343 0840934 Live/Registered |
CODMAN & SHURTLEFF, INC. 1966-11-10 |
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