FDA UDI
In Commercial Distribution
🇺🇸 United States
Labotect
DI: 04046668003294
·
Model: Ovarian Biopsy Set No. 1
·
Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Labotect
- Primary DI
- 04046668003294
- Version / Model
- Ovarian Biopsy Set No. 1
- Catalog Number
- 16785
- Company Name
- Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317343861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-11
- Public Version
- 1
- Public Version Date
- 2019-10-21
- Public Version Status
- New
- Public Device Record Key
- 781eb821-e29a-402f-ab52-1b3c525697a4
Device Description
Single lumen puncture set with corroded echo marking for aspiration only
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MQE | Needle, Assisted Reproduction | Obstetrics/Gynecology | 884.6100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45433 | Assisted reproduction needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument used for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. The device may have a single or double lumen and may include a needle guide, such as those used with ultrasound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046668003294 | GS1 |
Customer Contacts
- Phone
- +49551505010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003056 | 000 |