FDA UDI
In Commercial Distribution
🇺🇸 United States
EXEL Spinal Needle
DI: 10020221269656
·
Model: 26965
·
Exel International
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
50
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Basic Information
- Brand Name
- EXEL Spinal Needle
- Primary DI
- 10020221269656
- Version / Model
- 26965
- Catalog Number
- 26965
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2024-04-10
- Public Version Status
- Update
- Public Device Record Key
- ab602d38-4720-4ee3-93e6-7e93cea80e45
Device Description
Spinal Needle, 22G x 2 3/4, QUINCKE BEVEL
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35212 | Spinal needle, single-use | A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20020221269653 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 10020221269656 | GS1 | ||||
| Unit of Use | 00020221269659 | GS1 | ||||
| Package | 30020221269650 | GS1 | Shipping carton | 4 | In Commercial Distribution | |
| Package | 40020221269657 | GS1 | Shipping carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895771 | 000 |