FDA UDI
In Commercial Distribution
🇺🇸 United States
Reveal
DI: 00724995184773
·
Model: 00711774
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Reveal
- Primary DI
- 00724995184773
- Version / Model
- 00711774
- Catalog Number
- 00711774
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-01
- Public Version
- 3
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- b47ff6eb-2172-4d60-9ce2-f14689dbb131
Device Description
The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy and is intended for gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope's view field.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCX | endoscopic irrigation/suction system | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58841 | Endoscope tissue removal cap, single-use | A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995184770 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00724995184773 | GS1 | ||||
| Previous | 00816765012697 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 15 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry