Epimed 107-1618
GUDID 10818788023688
RX-2™ Coudé® Epidural Needle 14g TW x 6.0"
EPIMED INTERNATIONAL, INC
Epidural needle, non-threaded| Primary Device ID | 10818788023688 |
| NIH Device Record Key | d611705f-ecad-44aa-be71-f0db36e74077 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epimed |
| Version Model Number | 107-1618 |
| Catalog Number | 107-1618 |
| Company DUNS | 799751953 |
| Company Name | EPIMED INTERNATIONAL, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com | |
| Phone | +1(800)866-3342 |
| customerservice@epimed.com |
Device Dimensions
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
| Length | 6 Inch |
| Needle Gauge | 14 Gauge |
Operating and Storage Conditions
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818788023681 [Primary] |
| GS1 | 10818788023688 [Package] Contains: 00818788023681 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K053318
FDA Product Code
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
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 | 2023-11-29 |
| Device Publish Date | 2023-11-21 |
On-Brand Devices [Epimed]
| 00818788023193 | PainBlocker™ 16g x 3" Hemi Cryoneuroablation Probe |
| 10818788023022 | Grounding Pad, 4" x 8" w/ Attached Cable |
| 10818788022988 | Grounding Pad Cable, 10" |
| 10818788022971 | Grounding Pad, 4" x 8" |
| 00818788022820 | PainBlocker™ Cryoneuroablation Probe Sterilization Tray |
| 00818788022806 | PainBlocker™ 18g x 6" Trocar Cryoneuroablation Probe |
| 00818788022790 | PainBlocker™ 18g x 6" Hemi Cryoneuroablation Probe |
| 00818788022783 | PainBlocker™ 16g x 6" Trocar Cryoneuroablation Probe |
| 00818788022776 | PainBlocker™ 16g x 3" Trocar Cryoneuroablation Probe |
| 00818788022769 | PainBlocker™ 16g x 6" Hemi Cryoneuroablation Probe |
| 00818788022752 | PainBlocker™ 15g x 6" Bevel Point Cryoneuroablation Probe |
| 00818788022745 | PainBlocker™ 14g x 6" Trocar Cryoneuroablation Probe |
| 00818788022738 | PainBlocker™ 14g x 6" Hemi Cryoneuroablation Probe |
| 00818788022721 | PainBlocker™ System |
| 00818788022714 | PainBlocker™ Cart |
| 10818788022667 | R-F™ Cannula Coudé® B Bevel 22g TW x 15cm w/ 10mm Active Tip |
| 10818788022650 | R-F™ Cannula Coudé® B-Bevel 22g x 10cm w/ 10mm Active Tip |
| 10818788022643 | R-F™ Cannula Coudé® B-Bevel 20g x 15cm w/ 10mm Active Tip |
| 10818788022636 | R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 10mm Active Tip |
| 10818788022629 | R-F™ Cannula Coudé® B-Bevel 18g x 15cm w/ 10mm Active Tip |
| 10818788022612 | R-F™ Cannula Coudé® B-Bevel 18g x 10cm w/ 10mm Active Tip |
| 10818788022605 | R-F™ Cannula Coudé® B-Bevel 16g x 15cm w/ 10mm Active Tip |
| 10818788022599 | R-F™ Cannula Coudé® B-Bevel 16g x 10cm w/ 10mm Active Tip |
| 10818788022582 | R-F™ Cannula Coudé® B Bevel 22g TW x 15cm w/ 5mm Active Tip |
| 10818788022575 | R-F™ Cannula Coudé® B-Bevel 22g x 10cm w/ 5mm Active Tip |
| 10818788022568 | R-F™ Cannula Coudé® B-Bevel 22g x 5cm w/ 5mm Active Tip |
| 10818788022551 | R-F™ Cannula Coudé® B Bevel 20g TW x 15cm w/ 5mm Active Tip |
| 10818788022544 | R-F™ Cannula Coudé® B-Bevel 20g x 10cm w/ 5mm Active Tip |
| 10818788022537 | R-F™ Cannula Coudé® B Bevel 20g RW x 5cm w/ 5mm Active Tip |
| 10818788022520 | R-F™ Cannula B Bevel 22g TW x 15cm w/ 10mm Active Tip |
| 10818788022513 | R-F™ Cannula B-Bevel 22g x 10cm w/ 10mm Active Tip |
| 10818788022506 | R-F™ Cannula B-Bevel 20g x 15cm w/ 10mm Active Tip |
| 10818788022490 | R-F™ Cannula B-Bevel 20g x 10cm w/ 10mm Active Tip |
| 10818788022483 | R-F™ Cannula B-Bevel 18g x 15cm w/ 10mm Active Tip |
| 10818788022476 | R-F™ Cannula B-Bevel 18g x 10cm w/ 10mm Active Tip |
| 10818788022469 | R-F™ Cannula B Bevel 22g TW x 15cm w/ 5mm Active Tip |
| 10818788022452 | R-F™ Cannula B-Bevel 22g x 10cm w/ 5mm Active Tip |
| 10818788022445 | R-F™ Cannula B-Bevel 22g x 5cm w/ 5mm Active Tip |
| 10818788022438 | R-F™ Cannula B-Bevel 20g x 15cm w/ 5mm Active Tip |
| 10818788022421 | R-F™ Cannula B-Bevel 20g x 10cm w/ 5mm Active Tip |
| 10818788022414 | R-F™ Cannula B Bevel 20g TW x 5cm w/ 5mm Active Tip |
| 10818788022377 | R-F Cannula Coudé Blunt 22g TW x 10cm with 15mm Active Tip |
| 10818788022360 | R-F Cannula Coudé Blunt 22g TW x 10cm with 3mm Active Tip |
| 10818788022353 | R-F Cannula Blunt 22g TW x 15cm with 15mm Active Tip |
| 10818788022346 | R-F Cannula Blunt 22g TW x 10cm with 15mm Active Tip |
| 10818788022339 | R-F Cannula Blunt 20g TW x 10cm with 15mm Active Tip |
| 10818788022322 | R-F Cannula Blunt 22g TW x 15cm with 3mm Active Tip |
| 10818788022315 | R-F Cannula Blunt 22g TW x 10cm with 3mm Active Tip |
| 10818788022285 | RX-2 Coudé Epidural Needle 13g TW x 6.0" |
| 10818788022278 | RX-2 Coudé Coude Epidural Needle 13g TW x 4.0" |
Trademark Results [Epimed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIMED 85328075 4192855 Live/Registered |
EPIMED INTERNATIONAL, INC. 2011-05-23 |
 EPIMED 85328059 4192854 Live/Registered |
EPIMED INTERNATIONAL, INC. 2011-05-23 |
 EPIMED 75338282 2312847 Dead/Cancelled |
PROVANTAGE HEALTH SERVICES, INC. 1997-08-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.