FDA UDI
In Commercial Distribution
🇺🇸 United States
De Soutter Medical
DI: 05051471215283
·
Model: 21530
·
DE SOUTTER MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- De Soutter Medical
- Primary DI
- 05051471215283
- Version / Model
- 21530
- Catalog Number
- 21530
- Company Name
- DE SOUTTER MEDICAL LIMITED
- Labeler DUNS
- 458064144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-04
- Public Version
- 1
- Public Version Date
- 2025-12-12
- Public Version Status
- New
- Public Device Record Key
- 521c379d-c4a6-48b7-a533-70c8299cdfb3
Device Description
IRRIGATION SLEEVE - FOR USE WITH AV-220 (9770)
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64593 | Medical/surgical interventional tube/cable securement clip, reusable | A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051471215283 | GS1 |