FDA UDI
Not in Commercial Distribution
🇺🇸 United States
andorate® 2-piece Cleaning Adapter Kit
DI: 04897106951413
·
Model: GAR3875
·
GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- andorate® 2-piece Cleaning Adapter Kit
- Primary DI
- 04897106951413
- Version / Model
- GAR3875
- Company Name
- GA Health Company Limited
- Labeler DUNS
- 686908512
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-12
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 439c38d0-83dd-450d-bc80-b14ad0203b72
- Distribution End Date
- 2021-05-24
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38835 | Surgical instrument/endoscope cleaning utensil, single-use | A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14897106951410 | GS1 | Box | 25 | Not in Commercial Distribution | 2021-05-24 |
| Primary | 04897106951413 | GS1 | ||||
| Package | 24897106951417 | GS1 | Carton | 4 | Not in Commercial Distribution | 2021-05-24 |