FDA UDI
In Commercial Distribution
🇺🇸 United States
CELERO-12
DI: 15420045504929
·
Model: CELERO-12
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CELERO-12
- Primary DI
- 15420045504929
- Version / Model
- CELERO-12
- Catalog Number
- CELERO-12
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-26
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 8390b8e5-c3bd-49f7-986f-e40a23214858
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58990 | Side-notch biopsy gun handpiece/needle | A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045504929 | GS1 | ||||
| Package | 35420045504923 | GS1 | BOX | 5 | In Commercial Distribution | |
| Package | 25420045504926 | GS1 | BOX | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K034021 | 000 |