FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Dual Action Tissue Closure Device
DI: 06932503535564
·
Model: STA00006
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Dual Action Tissue Closure Device
- Primary DI
- 06932503535564
- Version / Model
- STA00006
- 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
- 5
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 70c601e2-9fd0-4b3d-aaa7-3480b6f5a47a
Device Description
Uncoated,20 copies per box
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| PLK | Tympanic Membrane Direct Contact Hearing Aid | Ear, Nose, Throat | 874.3315 | 2 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06932503535564 | GS1 | ||||
| Package | 16932503535561 | GS1 | BOX | 1 | In Commercial Distribution | |
| Package | 26932503535568 | GS1 | CASE | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2350 | Millimeter | |
| Outer Diameter | 3.0 | Millimeter |