GENTLECATH GLIDE
GUDID 00768455168545
GentleCath Glide Tiemann CH10
CONVATEC, PURCHASING DEPARTMENT
Single-administration urethral drainage catheter| Primary Device ID | 00768455168545 |
| NIH Device Record Key | 7c69dde8-2c82-4b7c-a8a0-010762734897 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENTLECATH GLIDE |
| Version Model Number | 510470 |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| 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 | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00768455168545 [Package] Contains: 00768455168712 Package: [10 Units] In Commercial Distribution |
| GS1 | 00768455168712 [Primary] |
| GS1 | 00768455168880 [Package] Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181206
FDA Product Code
| GBM | CATHETER, URETHRAL |
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 | 2023-11-07 |
| Device Publish Date | 2023-10-30 |
On-Brand Devices [GENTLECATH GLIDE]
| 00768455205417 | GentleCath Glide Female CH16 (1x30pk) |
| 00768455205400 | GentleCath Glide Female CH14 (1x30pk) |
| 00768455205394 | GentleCath Glide Female CH12 (1x30pk) |
| 00768455202300 | GentleCath Glide Female CH10 (1x30pk) |
| 00768455202294 | GentleCath Glide Female CH08 (1x30pk) |
| 00768455202287 | GentleCath Glide Male CH18 (1x30pk) |
| 00768455205356 | GentleCath Glide Male CH16 (1x30pk) |
| 00768455205349 | GentleCath Glide Male CH14 (1x30pk) |
| 00768455205332 | GentleCath Glide Male CH12 (1x30pk) |
| 00768455202249 | GentleCath Glide Male CH10 (1x30pk) |
| 00768455205318 | GentleCath Glide Male CH08 (1x30pk) |
| 00768455169030 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455169023 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168675 | GentleCath Glide |
| 00768455169009 | GentleCath Glide Femenino CH10 |
| 00768455168651 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168644 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168613 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168941 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168590 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168927 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168910 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168569 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168545 | GentleCath Glide Tiemann CH10 |
| 00768455168873 | GentleCath™ Glide Intermittent Urinary Catheter |
| 00768455168552 | GentleCath™ Glide Intermittent Urinary Catheter |
Trademark Results [GENTLECATH GLIDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLECATH GLIDE 88317215 not registered Live/Pending |
Unomedical A/S 2019-02-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.