FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327586589
·
Model: HAR1136
·
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327586589
- Version / Model
- HAR1136
- Catalog Number
- HAR1136
- Company Name
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Labeler DUNS
- 020198912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-04
- Public Version
- 1
- Public Version Date
- 2024-03-12
- Public Version Status
- New
- Public Device Record Key
- 45d6b2b7-90f5-4798-a7db-d815dba20ab4
Device Description
Ultrasonic Scalpel Shears with Advanced Hemostasis
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 |
|---|---|---|---|---|
| NLQ | Single-use reprocessed ultrasonic surgical instruments | Unknown | U | |
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61845 | Soft-tissue ultrasonic surgical system holder/tip, reprocessed | A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, and is typically made of metal. This device is utilized in a variety of surgical disciplines. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57613327586584 | GS1 | case | 6 | In Commercial Distribution | |
| Primary | 07613327586589 | GS1 |
Customer Contacts
- Phone
- +1(888)888-3433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233471 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 5.0 Millimeter | ||
| Length | 36.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius