Renew Inserts
- Primary DI
- 10867476000029
- Brand
- Renew Inserts
- Company
- RENEW MEDICAL INC
- Model
- 702
- Catalog number
- 702
- Device description
- Starter Pack of 10 individually packaged Renew Inserts consisting of 5 regular size and 5 large size Inserts
- Published
- 2016-09-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
renew-medical.comProduct Codes#
| Code | Name |
|---|---|
| PBP | Rectal Insert |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PBP | Rectal Insert | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K122003 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10867476000029 | Package | GS1 | 48 | In Commercial Distribution |
| 00867476000022 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10867476000029 | 10867476000029 | ||
| 00867476000022 | 00867476000022 | 867476000022 | 0867476000022 |
GMDN Terms#
| Term | Definition |
|---|---|
| Anal plug, single-use | A device designed to be inserted into the rectum by the user and retained there as a barrier to the passage of stool for the prevention of the involuntary evacuation of stool (faeces) in persons who are incontinent of bowel. It is typically made of plastic foam materials which expand upon contact with rectal moisture; it is available in a variety of sizes. The device may also be known as an anal tampon and is intended to be replaced after each rectal void. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-888-987-2929 | ricky@renew-medical.com |
Regulatory Flags#
- DUNS number
- 967228474
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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 |
|---|---|---|---|---|
| 00861680000458 | Navina Inserts | 69301 | 69301 | 2019-01-18 |
| 00861680000465 | Navina Inserts | 69302 | 69302 | 2019-01-18 |
| 00861680000472 | Navina Inserts | 69303 | 69303 | 2019-01-18 |
| 00867476000022 | Renew Inserts | 702 | 702 | 2016-09-16 |
| 00867476000039 | Renew Inserts | 706 | 706 | 2016-09-16 |
| 00867476000046 | Renew Inserts | 707 | 707 | 2016-09-16 |
| 00861680000403 | Renew Inserts | FG730 | FG730 | 2017-10-01 |
| 00861680000410 | Renew Inserts | FG731 | FG731 | 2017-10-01 |
| 00861680000427 | Renew Inserts | FG715 | FG715 | 2017-10-01 |
| 10867476000036 | Renew Inserts | 706 | 706 | 2016-09-16 |
| 10867476000043 | Renew Inserts | 707 | 707 | 2016-09-16 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00865453000331 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000348 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000362 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000379 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000324 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000355 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000300 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00865453000317 | StaySure | Minnesota Medical Technologies Corporation | PBP | 2026-03-23 |
| 00861680000458 | Navina Inserts | RENEW MEDICAL INC | PBP | 2019-01-18 |
| 00861680000465 | Navina Inserts | RENEW MEDICAL INC | PBP | 2019-01-18 |
| 00861680000472 | Navina Inserts | RENEW MEDICAL INC | PBP | 2019-01-18 |
| 00861680000403 | Renew Inserts | RENEW MEDICAL INC | PBP | 2017-10-01 |
| 00861680000410 | Renew Inserts | RENEW MEDICAL INC | PBP | 2017-10-01 |
| 00861680000427 | Renew Inserts | RENEW MEDICAL INC | PBP | 2017-10-01 |
| 00867476000022 | Renew Inserts | RENEW MEDICAL INC | PBP | 2016-09-16 |
| 00867476000039 | Renew Inserts | RENEW MEDICAL INC | PBP | 2016-09-16 |
| 00867476000046 | Renew Inserts | RENEW MEDICAL INC | PBP | 2016-09-16 |
| 10867476000036 | Renew Inserts | RENEW MEDICAL INC | PBP | 2016-09-16 |
| 10867476000043 | Renew Inserts | RENEW MEDICAL INC | PBP | 2016-09-16 |