AVANOS
- Primary DI
- 10350770928101
- Brand
- AVANOS
- Company
- Avanos Medical, Inc.
- Model
- 92810
- Catalog number
- 69392
- Device description
- * Foreign Body Retrieval Hood Protector
- Published
- 2019-06-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
avanos.comProduct Codes#
| Code | Name |
|---|---|
| FED | endoscopic access overtube, gastroenterology-urology |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K841258 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10350770928101 | Package | GS1 | 10 | In Commercial Distribution |
| 00350770928104 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10350770928101 | 10350770928101 | ||
| 00350770928104 | 00350770928104 | 350770928104 | 0350770928104 |
GMDN Terms#
| Term | Definition |
|---|---|
| Medical device cleaning sponge/pad | A hand-held device in the form of a sponge or pad intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. It may be soft or abrasive, and may contain non-medicated substances (e.g., enzymes, surfactant) to facilitate cleaning. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(844)428-2667 | PIQ@AVANOS.COM |
Regulatory Flags#
- DUNS number
- 079375431
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00350770005881 | CORTRAK* 2 Enteral Access System | 120002806 | P20-0950 | 2026-09-30 |
| 00350770007915 | CORTRAK* 2 Enteral Access System | 120008583 | 20-0950 | 2026-09-30 |
| 10680651135718 | Halyard | 13571 | PM006 | 2016-08-10 |
| 10680651136128 | Halyard | 13612 | PM002 | 2016-08-10 |
| 10680651136135 | Halyard | 13613 | PM003 | 2016-08-10 |
| 10680651136142 | Halyard | 13614 | PM004 | 2016-08-10 |
| 10680651136159 | Halyard | 13615 | PM005 | 2016-08-10 |
| 00193494135713 | ON-Q* Pain Relief System | 13571 | PM006 | 2020-05-07 |
| 00193494136123 | ON-Q* Pain Relief System | 13612 | PM002 | 2020-05-07 |
| 00193494136130 | ON-Q* Pain Relief System | 13613 | PM003 | 2020-05-07 |
| 00193494136147 | ON-Q* Pain Relief System | 13614 | PM004 | 2020-05-07 |
| 00193494136154 | ON-Q* Pain Relief System | 13615 | PM005 | 2020-05-07 |
| 00193493001088 | SINGLE SHOT EPIDURAL TRAY | 120008532 | 182A273 | 2026-08-21 |
| 00350770006840 | CORTRAK* Enteral Access System | 120008508 | P20-0950 | 2026-08-21 |
| 00350770007922 | CORTRAK* Enteral Access System - Reusable Cable | 120006252 | 20-0966 | 2026-08-21 |
| 00350770009094 | CORTRAK* Enteral Access System | 120008904 | 20-0950 | 2026-08-21 |
| 00350770009117 | CORTRAK* Enteral Access System - Reusable Cable | 120008872 | 20-0966 | 2026-08-21 |
| 00350770007557 | CORFLO* Safety PEG Kit | 120008662 | 30-5320 | 2026-08-14 |
| 00350770008868 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004764 | BA-S05NC | 2026-08-15 |
| 00350770008875 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004831 | BA-S12NC | 2026-08-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00191506062514 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062521 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062538 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062545 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062552 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062569 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062576 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062583 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062590 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 06942804744602 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744619 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744626 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744633 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744640 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744657 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744664 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744671 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744688 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744695 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744701 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744718 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744725 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744732 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744749 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744756 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744763 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744770 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744787 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744794 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744800 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |