FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPY
DI: 10858701006213
·
Model: SK6000
·
Novadaq Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SPY
- Primary DI
- 10858701006213
- Version / Model
- SK6000
- Catalog Number
- SK6000
- Company Name
- Novadaq Technologies Inc
- Labeler DUNS
- 243730939
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 5
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- be3abd73-bff6-4313-ab5f-63d0f229a02c
- Distribution End Date
- 2021-06-20
Device Description
SPY2000 drug and drape kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IZI | System, x-ray, angiographic | Radiology | 892.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44057 | General surgical procedure kit, medicated | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20858701006210 | GS1 | pack | 6 | Not in Commercial Distribution | 2021-06-20 |
| Primary | 10858701006213 | GS1 |
Customer Contacts
- Phone
- +1(604)232-9861
- [email protected]