FDA UDI
In Commercial Distribution
🇺🇸 United States
Endoscopic Injection Needle
DI: 00858015005943
·
Model: 101087
·
Carbon Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Endoscopic Injection Needle
- Primary DI
- 00858015005943
- Version / Model
- 101087
- Catalog Number
- 101087
- Company Name
- Carbon Medical Technologies, Inc.
- Labeler DUNS
- 883094039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f30b09bd-cca6-4f1a-9c07-3a63356bc263
Device Description
Endoscopic Injection Needle
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 10858015005940 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 00858015005943 | GS1 |
Customer Contacts
- Phone
- 8882070262
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172227 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Length; 8.0 mm | ||
| Device Size Text, specify | Catheter Diameter; 2.5 mm | ||
| Needle Gauge | 19 | Gauge | |
| Length | 140 | Centimeter |