FDA UDI
In Commercial Distribution
🇺🇸 United States
Morrison Steerable Needle
DI: 07350031355505
·
Model: 13550
·
Apriomed AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Morrison Steerable Needle
- Primary DI
- 07350031355505
- Version / Model
- 13550
- Catalog Number
- 13550
- Company Name
- Apriomed AB
- Labeler DUNS
- 631734758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 5
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- b11e47c7-6a39-4be9-96ca-010fe03fac88
Device Description
Morrison Steerable Needle 21G 17cm. Percutaneous injection and aspiration procedures and tissue sampling in liver, kidney, muscle and subcutaneous tissue.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 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 | 27350031355509 | GS1 | Transportation box | 18 | In Commercial Distribution | |
| Package | 17350031355502 | GS1 | Shelf box | 10 | In Commercial Distribution | |
| Primary | 07350031355505 | GS1 |
Customer Contacts
- Phone
- +46184301440
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150625 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Centimeter | |
| Needle Gauge | 21 | Gauge |