FDA UDI
In Commercial Distribution
🇺🇸 United States
17G Wallace Single Lumen Oocyte Recovery Set
DI: 00888937020991
·
Model: ONS1733LL-500
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 17G Wallace Single Lumen Oocyte Recovery Set
- Primary DI
- 00888937020991
- Version / Model
- ONS1733LL-500
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-04
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- dd6b2f17-49a7-4f5f-bb30-052fbc1af94a
Device Description
17G Wallace Single Lumen Oocyte Recovery Set, 500 mm tubing, flushing connector (Box of 10)
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
- Yes
- 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 |
|---|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45676 | IVF oocyte aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30888937020992 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 20888937020995 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00888937020991 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 500 | Millimeter | |
| Needle Gauge | 17 | Gauge |