FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00849771050544
·
Model: Vascular Loops
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00849771050544
- Version / Model
- Vascular Loops
- Catalog Number
- VL201
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 1
- Public Version Date
- 2024-03-19
- Public Version Status
- New
- Public Device Record Key
- 0d51aa98-4358-4a5d-80c3-b6e38eea8e16
Device Description
Vascular Loops, Sterile, Red, Mini, 2 per package
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| KDC | INSTRUMENT, SURGICAL, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
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 | 10849771050541 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00849771050544 | GS1 | ||||
| Previous | 00849771030836 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K896676 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter Cross Section 1.3mm x 0.9mm | ||
| Length | 18 | Inch |