FDA UDI
In Commercial Distribution
🇺🇸 United States
Intro
DI: 08056138586536
·
Model: PT17044
·
M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Intro
- Primary DI
- 08056138586536
- Version / Model
- PT17044
- Catalog Number
- PT17044
- Company Name
- M.D.L. S.R.L.
- Labeler DUNS
- 447228586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-14
- Public Version
- 2
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- 4692074f-8c79-4de9-a692-9a75c613a98b
Device Description
COAXIAL INTRODUCER NEEDLE 17G X 44 mm
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
- 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 |
|---|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62257 | Orthopaedic coaxial injection applicator | A tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18056138586533 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08056138586536 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 44 | Millimeter | |
| Needle Gauge | 17 | Gauge |