TRANSFORM SRC0410
GUDID 07613327004441
C Compliant Occlusion Balloon Catheter
Stryker Corporation
Intravascular occluding balloon catheter, image-guided| Primary Device ID | 07613327004441 |
| NIH Device Record Key | df3220f5-072e-4bc5-9e6d-dcd24f5a1595 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRANSFORM |
| Version Model Number | M003SRC04100 |
| Catalog Number | SRC0410 |
| Company DUNS | 042405446 |
| Company Name | Stryker Corporation |
| 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
Device Dimensions
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
| Length | 10 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327004441 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122576
FDA Product Code
| MJN | Catheter, intravascular occluding, temporary |
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 | 2019-03-21 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [TRANSFORM]
| 07613327004717 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004700 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004694 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004687 | C Compliant Occlusion Balloon Catheter |
| 07613327004526 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004519 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004502 | SC Super Compliant Occlusion Balloon Catheter |
| 07613327004496 | C Compliant Occlusion Balloon Catheter |
| 07613327004489 | C Compliant Occlusion Balloon Catheter |
| 07613327004472 | C Compliant Occlusion Balloon Catheter |
| 07613327004465 | C Compliant Occlusion Balloon Catheter |
| 07613327004458 | C Compliant Occlusion Balloon Catheter |
| 07613327004441 | C Compliant Occlusion Balloon Catheter |
| 07613327004434 | C Compliant Occlusion Balloon Catheter |
| 07613327004427 | C Compliant Occlusion Balloon Catheter |
| 07613327004410 | C Compliant Occlusion Balloon Catheter |
Trademark Results [TRANSFORM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRANSFORM 98712112 not registered Live/Pending |
Transform Charleston, LLC 2024-08-22 |
 TRANSFORM 98555809 not registered Live/Pending |
Kingsnorth, Thomas 2024-05-17 |
 TRANSFORM 98316227 not registered Live/Pending |
Water Pik, Inc. 2023-12-15 |
 TRANSFORM 98045041 not registered Live/Pending |
AS America, Inc. 2023-06-15 |
 TRANSFORM 90597436 not registered Live/Pending |
American Sports Licensing, LLC 2021-03-23 |
 TRANSFORM 90461135 not registered Live/Pending |
Ramsden, Jean A 2021-01-12 |
TRANSFORM 90461135 not registered Live/Pending |
Matthew Ramsden 2021-01-12 |
 TRANSFORM 88900244 not registered Live/Pending |
TransFORM 2020-05-04 |
 TRANSFORM 88863992 not registered Live/Pending |
Cudanin, Vicki L. 2020-04-08 |
 TRANSFORM 88490571 not registered Live/Pending |
MEET HEAD BRANDS, LLC 2019-06-26 |
 TRANSFORM 88487923 not registered Live/Pending |
Gatherlab 2019-06-25 |
 TRANSFORM 88469702 not registered Live/Pending |
Gambro Lundia AB 2019-06-12 |
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