FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 07613327117011
·
Model: 0950221000
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327117011
- Version / Model
- 0950221000
- Catalog Number
- 0950221000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- ab18b07e-7863-48b6-bb0b-ac0afc052c2d
- Distribution End Date
- 2018-01-05
Device Description
Coax Chiba Needle Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
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 | 37613327117012 | GS1 | pack | 10 | Not in Commercial Distribution | 2018-01-05 |
| Primary | 07613327117011 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 19.0 | Gauge | |
| Length | 10.0 | Centimeter | |
| Length | 14.9 | Centimeter | |
| Needle Gauge | 22.0 | Gauge |