FDA UDI
In Commercial Distribution
🇺🇸 United States
Spray Catheter
DI: 06932503562256
·
Model: WP-18/2500
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Spray Catheter
- Primary DI
- 06932503562256
- Version / Model
- WP-18/2500
- 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
- 2025-04-30
- Public Version
- 2
- Public Version Date
- 2025-12-02
- Public Version Status
- Update
- Public Device Record Key
- 1c0e43ed-3810-4ce7-aaa5-b4714c77cb94
Device Description
Blue handle 1.8mm OD 2500mm length
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
- Yes
- 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 |
|---|---|---|---|---|
| GCE | Adaptor, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61511 | Endoscopic spray catheter, single-use | A flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal colouration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503562253 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 06932503562256 | GS1 | ||||
| Package | 26932503562250 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 250 | Centimeter | |
| Outer Diameter | 1.8 | Millimeter |