GYNECARE INTERCEED 4350
GUDID 20705031005393
Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose
ETHICON, LLC
Surgical anti-adhesion dressing, implantable, bioabsorbable| Primary Device ID | 20705031005393 |
| NIH Device Record Key | deb4d0e7-4a44-4772-ac59-7fea6e1177d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GYNECARE INTERCEED |
| Version Model Number | 4350 |
| Catalog Number | 4350 |
| Company DUNS | 829465157 |
| Company Name | ETHICON, LLC |
| 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(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031005396 [Primary] |
| GS1 | 20705031005393 [Package] Contains: 10705031005396 Package: CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P880047
FDA Product Code
| MCN | BARRIER, ABSORABLE, ADHESION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2014-09-20 |
On-Brand Devices [GYNECARE INTERCEED]
| 20705031005393 | Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose |
| 20705031147840 | Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose |
Trademark Results [GYNECARE INTERCEED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GYNECARE INTERCEED 76685064 3814857 Live/Registered |
JOHNSON & JOHNSON 2007-12-17 |
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