FDA UDI
In Commercial Distribution
🇺🇸 United States
Ancora
DI: 10860006600805
·
Model: Ancora-SB 4-pack
·
Aspero Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Ancora
- Primary DI
- 10860006600805
- Version / Model
- Ancora-SB 4-pack
- Company Name
- Aspero Medical, Inc.
- Labeler DUNS
- 081317957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- f06e459f-6e18-491f-b782-f6a708ef6c65
Device Description
Balloon Overtube Assembly, package of 4
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 |
|---|---|---|---|---|
| FDA | Enteroscope And Accessories | Gastroenterology, Urology | 876.1500 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46687 | Endoscopic overtube, single-use | A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10860006600805 | GS1 | ||||
| Unit of Use | 00860006600808 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231323 | 000 |