FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OcciGuide
DI: M710ERGUIDE10100
·
Model: 048-1000
·
BIOTEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- OcciGuide
- Primary DI
- M710ERGUIDE10100
- Version / Model
- 048-1000
- Catalog Number
- ER GUIDE 1010
- Company Name
- BIOTEX, INC.
- Labeler DUNS
- 969792050
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-25
- Public Version
- 5
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 8355a55c-cf72-4bc0-9e36-5272cc1626a7
- Distribution End Date
- 2023-08-31
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | 878.4800 | 1 |
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 | M710ERGUIDE10102 | HIBCC | Shelf carton | 10 | Not in Commercial Distribution | 2023-08-31 |
| Primary | M710ERGUIDE10100 | HIBCC |
Customer Contacts
- Phone
- 7137410111
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 121 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 121 Degrees Celsius