FDA UDI
In Commercial Distribution
🇺🇸 United States
Endocuff
DI: 05060423410096
·
Model: AEC120
·
BODDINGTONS PLASTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Endocuff
- Primary DI
- 05060423410096
- Version / Model
- AEC120
- Company Name
- BODDINGTONS PLASTICS LIMITED
- Labeler DUNS
- 216745893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 6
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- 4b62fc06-2cce-4d34-a557-a4474dd27e62
Device Description
AEC120 Size 2 (L) Endocuff Sterile Green- 1 pot - single unit
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60911 | Colonoscope distal anchoring cuff | A device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060423410096 | GS1 | ||||
| Package | 5060423410010 | GS1 | Carton | 8 | In Commercial Distribution | |
| Package | 5060423410133 | GS1 | Shipper | 120 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 11.2 | Millimeter |