FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Disposable Endocavity Needle Guide Kit
DI: 00841912105267
·
Model: 9005
·
PROTEK MEDICAL PRODUCTS, INC.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterile Disposable Endocavity Needle Guide Kit
- Primary DI
- 00841912105267
- Version / Model
- 9005
- Catalog Number
- 9005
- Company Name
- PROTEK MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 965417181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-22
- Public Version
- 12
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 52d3643d-6b98-4b04-a4c8-873a5a187f63
Device Description
Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3
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
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60608 | Body-orifice ultrasound imaging transducer cover, basic | A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. | No | Active |
| 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 | 10841912105264 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 00841912105267 | GS1 |