FDA UDI
In Commercial Distribution
🇺🇸 United States
Closed Needle Guide
DI: 00813079020400
·
Model: LNGC-14
·
REMINGTON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Closed Needle Guide
- Primary DI
- 00813079020400
- Version / Model
- LNGC-14
- Catalog Number
- LNGC-14
- Company Name
- REMINGTON MEDICAL, INC.
- Labeler DUNS
- 788472314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 4
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 999f8b8a-94f4-418c-a57f-54edfc4278b7
Device Description
14ga (2.1mm)
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZH | System, x-ray, mammographic | Radiology | 892.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45018 | Needle guide, single-use | A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813079020407 | GS1 | Inner Carton | 10 | In Commercial Distribution | |
| Primary | 00813079020400 | GS1 | ||||
| Package | 20813079020404 | GS1 | Shipping Carton | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)989-0057
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983621 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 14 | Gauge |