ETHICON 3921S
GUDID 20705031230139
Evicel Airless Spray Accessory
ETHICON INC.
Haematological concentrate applicator| Primary Device ID | 20705031230139 |
| NIH Device Record Key | 93268a0d-942e-46e5-8722-4dfaceedf977 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ETHICON |
| Version Model Number | 3921S |
| Catalog Number | 3921S |
| Company DUNS | 002144145 |
| Company Name | ETHICON 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 | 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 | |
| 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 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 |
| 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 |
| 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 | 10705031230132 [Primary] |
| GS1 | 20705031230139 [Package] Contains: 10705031230132 Package: BOX [10 Units] In Commercial Distribution |
| GS1 | 30705031230136 [Package] Contains: 10705031230132 Package: CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK140093
FDA Product Code
| FMF | Syringe, piston |
| MZM | Fibrin sealant preparation device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2015-09-23 |
On-Brand Devices [ETHICON]
| 20705031240466 | Evicel Laparoscopic Airless Spray Accessory |
| 20705031230139 | Evicel Airless Spray Accessory |
| 20705031147833 | EVICEL 4CM CONTROL TIP (SET OF 10) |
| 20705031131955 | Surgiflo Endoscopic Appicator |
| 10705031007239 | EVICEL 5 ML DEVICE |
| 10705031007215 | EVICEL 1/2 ML DEVICE |
| 20705031005089 | EVICEL 45CM FLEXIBLE TIP (SET OF 3) |
| 20705031005072 | EVICEL 35 CM APPLICATOR TIP |
| 30705031238903 | Pull-out Suture Set Surgical Steel w/ Monofilament 316L Stainless Steel 4-0 8" Loop |
| 20705031036823 | BONE WAX |
| 30705031462728 | Laparoscopic Dual Flexible Applicator |
| 20705031462578 | Laparoscopic Dual Rigid Applicator |
| 20705031462530 | VISTASEAL DUAL APPLICATOR |
| 30705031050413 | Chromic Suture Chromic Monofilament |
| 30705031028962 | Chromic Gut, Sterile, Absorbable Surgical Suture |
| 10705031228139 | CO2 Pressure Regulator |
Trademark Results [ETHICON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ETHICON 73096039 1080331 Dead/Expired |
JOHNSON & JOHNSON 1976-08-09 |
 ETHICON 72459699 0988520 Dead/Expired |
JOHNSON & JOHNSON 1973-06-08 |
 ETHICON 72443256 0972367 Live/Registered |
ETHICON, INC. 1972-12-08 |
 ETHICON 72442377 0971196 Dead/Expired |
ETHICON, INC. 1972-11-29 |
 ETHICON 72090319 0706542 Live/Registered |
ETHICON, INC. 1960-02-04 |
 ETHICON 72036068 0662658 Live/Registered |
ETHICON, INC. 1957-08-23 |
 ETHICON 71648239 0599432 Live/Registered |
ETHICON SUTURE LABORATORIES INCORPORATED 1953-06-04 |
 ETHICON 71566597 0522718 Dead/Expired |
JOHNSON & JOHNSON 1948-10-07 |
 ETHICON 71279404 0270970 Dead/Expired |
JOHNSON & JOHNSON 1929-02-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.