FDA UDI
In Commercial Distribution
🇺🇸 United States
Template Grid
DI: 10841436104668
·
Model: 610-977, H46222LP
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Template Grid
- Primary DI
- 10841436104668
- Version / Model
- 610-977, H46222LP
- Catalog Number
- 610-977, H46222LP
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 5
- Public Version Date
- 2022-08-23
- Public Version Status
- Update
- Public Device Record Key
- c8f05956-da99-4333-b001-c32183a24405
Device Description
Sterile guide accepts 14GA instruments or 2.4mm therapeutic probes. For use with CIVCO Classic and Multi-Purpose Workstation™ Steppers
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38426 | Prostate brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841436104661 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 10841436104668 | GS1 | ||||
| Package | 00841436109062 | GS1 | 5 | Not in Commercial Distribution | 2022-07-07 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972672 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8.5 | Centimeter | |
| Length | 7.3 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 52 – 85 Degrees Fahrenheit