FDA UDI
In Commercial Distribution
🇺🇸 United States
InjecSURE ®
DI: 10850002461418
·
Model: 890-310S
·
Carbon Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InjecSURE ®
- Primary DI
- 10850002461418
- Version / Model
- 890-310S
- Catalog Number
- 890-310S
- Company Name
- Carbon Medical Technologies, Inc.
- Labeler DUNS
- 883094039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- e9121d95-4106-4183-8040-d1dc0055a197
Device Description
Endoscopic Injection System
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
- Yes
- 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 |
|---|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850002461418 | GS1 |
Customer Contacts
- Phone
- 6516538512
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253598 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge | |
| Length | 127 | Millimeter | |
| Length | 5 | Inch | |
| Length | 110 | Millimeter | |
| Outer Diameter | 2.7 | Millimeter | |
| Angle | 0 | degree | |
| Device Size Text, specify | Spinal |