FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Endo-Boot
DI: 10816765013424
·
Model: 00711622
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Endo-Boot
- Primary DI
- 10816765013424
- Version / Model
- 00711622
- Catalog Number
- 00711622
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 5
- Public Version Date
- 2020-03-31
- Public Version Status
- Update
- Public Device Record Key
- c3007970-6d8d-4549-87ab-b46db9f7921f
- Distribution End Date
- 2020-03-31
Device Description
The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCU | Endoscopic storage cover | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46505 | Surgical instrument guard, single-use, sterile | A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20816765013421 | GS1 | Box | 2 | Not in Commercial Distribution | 2020-03-31 |
| Primary | 10816765013424 | GS1 | ||||
| Unit of Use | 00816765013427 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius