FDA UDI
In Commercial Distribution
🇺🇸 United States
KnifeLight
DI: 34546540060113
·
Model: 3300-001-000
·
Stryker Trauma SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- KnifeLight
- Primary DI
- 34546540060113
- Version / Model
- 3300-001-000
- Catalog Number
- 3300-001-000
- Company Name
- Stryker Trauma SA
- Labeler DUNS
- 481999654
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 6
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 0309ad11-37f3-465e-a3ff-59540561554e
Device Description
KNIFE LIGHT 10,PK
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
- No
- 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 |
|---|---|---|---|---|
| FTD | Lamp, surgical | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58783 | Hand ligament surgical release instrument | A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 34546540060113 | GS1 | ||||
| Unit of Use | 04546540060112 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 102.0 | Millimeter | |
| Width | 292.0 | Millimeter | |
| Length | 305.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius