Assurance
- Primary DI
- 10724995220690
- Brand
- Assurance
- Company
- US Endoscopy
- Model
- 00711927
- Catalog number
- 00711927
- Device description
- The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.
- Published
- 2023-03-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| PKL | Hemostatic metal clip for the GI tract |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K172727 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10724995220690 | Package | GS1 | 10 | In Commercial Distribution |
| 50724995220698 | Package | GS1 | 10 | In Commercial Distribution |
| 00724995220693 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10724995220690 | 10724995220690 | ||
| 50724995220698 | 50724995220698 | ||
| 00724995220693 | 00724995220693 | 724995220693 | 0724995220693 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)548-4873 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 627879687
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00724995182557 | Exacto | 00711094 | 00711094 | 2021-03-31 |
| 00724995182564 | Exacto | 00711095 | 00711095 | 2021-03-31 |
| 00724995182618 | Exacto | 00711115 | 00711115 | 2021-03-31 |
| 00724995243746 | Exacto Mundo | 00711114 | 00711114 | 2025-01-31 |
| 00724995180959 | VIA | 00717001 | 00717001 | 2020-01-31 |
| 00724995181116 | VIA | 00717019 | 00717019 | 2020-01-30 |
| 00724995181420 | VIA | 00717051 | 00717051 | 2020-01-30 |
| 00724995181451 | VIA | 00717054 | 00717054 | 2020-01-30 |
| 00724995181505 | VIA | 00717059 | 00717059 | 2020-01-30 |
| 00724995181659 | VIA | 00717076 | 00717076 | 2020-01-30 |
| 00724995182984 | VIA | 00717141 | 00717141 | 2020-01-30 |
| 00724995183073 | VIA | 00717155 | 00717155 | 2020-07-16 |
| 00724995183141 | VIA | 00717167 | 00717167 | 2020-01-30 |
| 00724995183257 | VIA | 00717182 | 00717182 | 2020-01-30 |
| 00724995190699 | VIA | 00717223 | 00717223 | 2020-01-30 |
| 00724995190736 | VIA | 00717234 | 00717234 | 2020-01-30 |
| 00724995193966 | VIA | 00717269 | 00717269 | 2020-02-04 |
| 00724995194123 | VIA | 00717229 | 00717229 | 2020-02-07 |
| 00724995194987 | VIA | 00717310 | 00717310 | 2020-03-23 |
| 00724995203412 | VIA | 00717337 | 00717337 | 2020-10-20 |
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