Cook
- Primary DI
- 00827002141018
- Brand
- Cook
- Company
- COOK INCORPORATED
- Model
- G14101
- Catalog number
- 110240
- Device description
- Malleable Tip Filiform
- Published
- 2020-10-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
cookmedical.comProduct Codes
| Code | Name |
|---|---|
| FBW | FILIFORM AND FILIFORM FOLLOWER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FBW | Filiform And Filiform Follower | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00827002141018 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00827002141018 | 00827002141018 | 827002141018 | 0827002141018 |
GMDN Terms
| Term | Definition |
|---|---|
| Urethral dilatation catheter, non-medicated | A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dark, dry, cool place. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(812)330-5494 | sharedservices@cookmedical.com |
Regulatory Flags
- DUNS number
- 042823948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00827002613508 | SureTome SW | G61350 | SUR-SW-35 | 2025-12-08 |
| 10827002613512 | SureTome SW | G61351 | SUR-SW-AWG2-35-260 | 2025-12-08 |
| 10827002613529 | SureTome SW | G61352 | SUR-SW-AWG2-35-450 | 2025-12-08 |
| 10827002242378 | Bakri | G24237 | J-SOSR-100500 | 2016-09-24 |
| 10827002306735 | Bakri | G30673 | J-SOS-100500 | 2016-09-24 |
| 00827002607842 | COOK | G60784 | TESLA-B2535-260 | 2025-07-22 |
| 00827002607859 | COOK | G60785 | TESLA-B2535-450 | 2025-07-22 |
| 10827002597508 | COOK | G59750 | TESLA-B-ACU | 2025-07-11 |
| 10827002496535 | Cotton-Leung Sof-Flex | G49653 | CLSO-SF-10-5 | 2015-11-03 |
| 00827002352674 | Hercules | G35267 | HBDE-W-8-9-10 | 2022-12-20 |
| 00827002352681 | Hercules | G35268 | HBDE-W-10-11-12 | 2022-12-20 |
| 00827002352698 | Hercules | G35269 | HBDE-W-12-13.5-15 | 2022-12-20 |
| 00827002352704 | Hercules | G35270 | HBDE-W-15-16.5-18 | 2022-12-20 |
| 00827002352711 | Hercules | G35271 | HBDE-W-18-19-20 | 2022-12-20 |
| 10827002346014 | Fusion | G34601 | FS-OMNI-ACRO-35-205 | 2016-09-24 |
| 10827002346939 | Fusion | G34693 | FS-OMNI-ACRO-35-260 | 2016-09-24 |
| 10827002347110 | Fusion | G34711 | FS-OMNI-ACRO-35-450 | 2016-09-24 |
| 10827002347783 | D.A.S.H. | G34778 | DASH-ACRO-35-450 | 2016-09-24 |
| 10827002347790 | D.A.S.H. | G34779 | DASH-ACRO-25-450 | 2016-09-24 |
| 10827002347806 | D.A.S.H. | G34780 | DASH-ACRO-35-260 | 2016-09-24 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00827002141001 | Cook | COOK INCORPORATED | FBW | 2020-10-15 |
| 00827002141025 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141032 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141049 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141056 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141063 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141070 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141087 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141094 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141100 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141117 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141124 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141131 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002141148 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002144774 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002147409 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002151086 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002151093 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002152052 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002179097 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00827002179202 | Cook | COOK INCORPORATED | FBW | 2020-10-02 |
| 00801741073083 | Woven Filiform Straight Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073090 | Woven Filiform Straight Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073106 | Woven Filiform Straight Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073113 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073120 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073137 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073144 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073151 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |
| 00801741073168 | Woven Filiform Spiral Tip | C. R. Bard, Inc. | FBW | 2020-09-04 |