FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327507119
·
Model: N/A
·
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327507119
- Version / Model
- N/A
- Catalog Number
- 30-401LITE
- Company Name
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Labeler DUNS
- 020198912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-26
- Public Version
- 1
- Public Version Date
- 2020-11-03
- Public Version Status
- New
- Public Device Record Key
- 3f4b528c-3a38-4b01-b634-367dab72c577
Device Description
MyoSure LITE Tissue Removal Device
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 |
|---|---|---|---|---|
| HIH | HYSTEROSCOPE (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62952 | Hysteroscopic resection device | A sterile, hand-held, manual surgical instrument intended to be inserted through the working channel of a hysteroscope to cut and remove uterine lesions (e.g., polyps), and may in addition be used to obtain a mucosal biopsy. It consists of a distal cannula with a side-notch and internal oscillating cutting blade, a proximal handle/operating mechanism, and may include a suction port; it does not have a snare mechanism and is not an electrosurgical device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57613327507114 | GS1 | case | 1 | In Commercial Distribution | |
| Package | 37613327507110 | GS1 | pack | 3 | In Commercial Distribution | |
| Primary | 07613327507119 | GS1 |
Customer Contacts
- Phone
- +1(888)888-3433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201756 | 000 |