FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRODUCER NEEDLE
DI: 08058983744192
·
Model: INTRODUCER NEEDLE
·
H.S. HOSPITAL SERVICE SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRODUCER NEEDLE
- Primary DI
- 08058983744192
- Version / Model
- INTRODUCER NEEDLE
- Catalog Number
- IN 20150N
- Company Name
- H.S. HOSPITAL SERVICE SPA
- Labeler DUNS
- 428898555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 2
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- da7e3cc1-0770-4cd3-8406-478cc6604ce8
Device Description
INTRODUCER NEEDLE 150MM PER AGO 20G
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
- Yes
- 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 |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60437 | Interventional radiology percutaneous-access kit, single-use | A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 48058983744190 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 08058983744192 | GS1 |
Customer Contacts
- Phone
- +39069201961
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter |