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 |
|---|---|---|---|---|
| 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 |
| 00350770008899 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004839 | BA-S60NC | 2026-08-15 |
| 00350770008912 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004765 | BP-S05NC | 2026-08-15 |
| 00350770008929 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004842 | BP-S12NC | 2026-08-15 |
| 00350770008943 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004847 | BP-S60NC | 2026-08-15 |
| 00350770008967 | NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector | 120004849 | NEO12 | 2026-08-15 |
| 00350770008981 | NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector | 120004852 | NEO60 | 2026-08-15 |
| 00350770009001 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004832 | BA-S12NC-S | 2026-08-15 |
| 00350770009018 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004869 | PNM-S12NC | 2026-08-15 |
| 00350770009032 | NEOMED* Oral / Enteral Syringe with ENFit® Connector | 120004874 | PNM-S35NC | 2026-08-15 |
| 00812120004895 | Game Ready* System | 120008544 | 550500-04 | 2026-07-31 |
| 00812120005076 | Game Ready* Full Leg Boot Wrap, Medium | 120008563 | 590923-04 | 2026-07-31 |
| 00812120005113 | Game Ready* Ankle Wrap, Large | 120008549 | 590330-04 | 2026-07-31 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10884450457372 | C2 CryoBalloon™ | Merit Medical Systems, Inc. | FED | 2026-08-21 |
| 06973356551462 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551479 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551493 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551509 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551660 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551677 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551684 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551691 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551707 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551714 | Proxiva | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-08-18 |
| 06973356551738 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551745 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551752 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551769 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551776 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06973356551783 | Trious | Shenzhen Trious Medical Technology Co., Ltd | FED | 2026-06-23 |
| 06936345101536 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345101543 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104469 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104476 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104483 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104490 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104544 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104551 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104568 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06936345104575 | Disposable Ureteral Guide Sheath | Dongguan ZSR Biomedical Technology Company Limited | FED | 2026-05-27 |
| 06970462547457 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FED | 2026-02-10 |
| 06970462547464 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FED | 2026-02-10 |
| 06970462547471 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FED | 2026-02-10 |