FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PrecisionGlide
DI: 30382904094097
·
Model: 409409
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- BD PrecisionGlide
- Primary DI
- 30382904094097
- Version / Model
- 409409
- Catalog Number
- 409409
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- afbf9914-a0ad-4be6-859f-120b634d9be7
Device Description
NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST
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
- Yes
- 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 |
|---|---|---|---|---|
| IZH | System, x-ray, mammographic | Radiology | 892.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35886 | Body aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382904094091 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 30382904094097 | GS1 | ||||
| Unit of Use | 00382904094096 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K881697 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature