FDA UDI
In Commercial Distribution
🇺🇸 United States
Stephens Instruments
DI: 00810799032874
·
Model: S4-1450
·
KRISHNA IMPORTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stephens Instruments
- Primary DI
- 00810799032874
- Version / Model
- S4-1450
- Catalog Number
- S4-1450
- Company Name
- KRISHNA IMPORTS INC
- Labeler DUNS
- 081853285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-22
- Public Version
- 2
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- bf46d9fb-daf7-4a63-9619-c0df3e1061c8
Device Description
Mccannel Iris Suture Needle Guide
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXK | HOLDER, NEEDLE; ORTHOPEDIC | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60734 | Needle guide, reusable | A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810799032874 | GS1 |
Customer Contacts
- Phone
- +1(859)259-4925
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature