FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cyst Puncture Needle without Stylet
DI: 07350025912417
·
Model: 14814
·
Vitrolife Sweden AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cyst Puncture Needle without Stylet
- Primary DI
- 07350025912417
- Version / Model
- 14814
- Company Name
- Vitrolife Sweden AB
- Labeler DUNS
- 631805488
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f562153e-909a-4571-9ca5-ee507c5dafdb
- Distribution End Date
- 2017-02-24
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 |
|---|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47994 | Endoscopic cyst-aspiration set | A collection of sterile devices designed to stabilize and aspirate a cyst or other internal anatomical structure under direct endoscopic vision during a surgical procedure, typically enabling aspiration of fluid without leakage into the surrounding anatomy (e.g., the peritoneal cavity). It typically consists of a long, slender, sharply-pointed, metal needle (e.g., stainless steel) within an aspiration tube [e.g., stainless steel or polycarbonate (PC)] that is applied to the lesion with suction; it may include adaptors and tubing to connect to the source of suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17350025912414 | GS1 | 5 | Not in Commercial Distribution | 2017-02-24 | |
| Primary | 07350025912417 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K862365 | 000 |