FDA UDI
In Commercial Distribution
🇺🇸 United States
De Soutter Medical
DI: 05051471161597
·
Model: 18680
·
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
- 05051471161597
- Version / Model
- 18680
- Catalog Number
- 18680
- Company Name
- DE SOUTTER MEDICAL LIMITED
- Labeler DUNS
- 458064144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 57c4e7ff-4e54-46e9-bcf0-8ec495c04b9c
Device Description
STERNUM GUARD - SPECIAL
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 |
|---|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44981 | Sternum saw blade guide | A protective device with a bulbous distal end used together with a sternal saw blade when cutting open the sternum (the breastbone) during cardiovascular surgery. The saw blade will operate within the confines of this device that protects the underlying organs from contact with the end of the reciprocating blade. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051471161597 | GS1 |