FDA UDI
In Commercial Distribution
🇺🇸 United States
MT
DI: 06932503563147
·
Model: ETS10008
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MT
- Primary DI
- 06932503563147
- Version / Model
- ETS10008
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-28
- Public Version
- 1
- Public Version Date
- 2023-07-06
- Public Version Status
- New
- Public Device Record Key
- 8d574224-1d01-41dd-93c0-1464c70bffe9
Device Description
ETD-C-26-235-C-N,LOCK-00008
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 |
|---|---|---|---|---|
| QSW | Endoscopic Traction Device | Gastroenterology, Urology | 876.4410 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63532 | Endoluminal self-retaining endoscopic retractor | A sterile self-retaining retraction device intended to be used during endoscopic gastrointestinal surgery to improve dissection and submucosal visualization, by providing tension by attachment to the area to be dissected and to the opposing wall within the gut lumen. The tether consists of an elastic stem with a clip at either end for attachment to the mucosa, and is supplied with dedicated grasping forceps and flexible catheter for delivery/positioning of the retractor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503563144 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 06932503563147 | GS1 | ||||
| Package | 26932503563141 | GS1 | CASE | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222354 | 000 |