FDA UDI
In Commercial Distribution
🇺🇸 United States
Degania
DI: 07290001603178
·
Model: 231031280DS
·
DEGANIA SILICONE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Degania
- Primary DI
- 07290001603178
- Version / Model
- 231031280DS
- Company Name
- DEGANIA SILICONE LTD
- Labeler DUNS
- 600007082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-09
- Public Version
- 2
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 6611a9e8-2ee1-44be-b2ee-dac05abd2edf
Device Description
Identi Loops Mini Blue18" sterile
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
- 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 |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61916 | Surgical vessel loop | A nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 47290001603176 | GS1 | carton | 10 | In Commercial Distribution | |
| Package | 27290001603172 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 07290001603178 | GS1 |