LoFric® Elle™ 4181250
GUDID 07333387024288
Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
Wellspect AB
Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use Intermittent urethral drainage catheter, non-antimicrobial, single-use| Primary Device ID | 07333387024288 |
| NIH Device Record Key | 3d9ac61a-854d-442a-8390-2b3543c59e15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LoFric® Elle™ |
| Version Model Number | 4181250 |
| Catalog Number | 4181250 |
| Company DUNS | 351118942 |
| Company Name | Wellspect AB |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
| Catheter Length | 4 Inch |
| Catheter Gauge | 12 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387024264 [Primary] |
| GS1 | 07333387024271 [Package] Contains: 07333387024264 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387024288 [Package] Contains: 07333387024271 Package: [2 Units] In Commercial Distribution |
| GS1 | 07392532274312 [Previous] |
FDA Product Code
| EZD | Catheter, straight |
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 | 2023-10-03 |
| Device Publish Date | 2023-09-25 |
On-Brand Devices [LoFric® Elle™]
| 07333387024608 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR |
| 07333387024455 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack |
| 07333387024288 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR |
| 07333387024080 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack |
| 07333387023908 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR |
| 07333387023755 | Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack |
Trademark Results [LoFric]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOFRIC 73423764 1324299 Live/Registered |
Astra Meditec Aktiebolag 1983-04-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.