FDA UDI
In Commercial Distribution
🇺🇸 United States
MTG Pediatric Intermittent Catheter, Coude-tip
DI: 00851593006258
·
Model: 71608
·
MEDICAL TECHNOLOGIES OF GEORGIA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MTG Pediatric Intermittent Catheter, Coude-tip
- Primary DI
- 00851593006258
- Version / Model
- 71608
- Company Name
- MEDICAL TECHNOLOGIES OF GEORGIA, INC.
- Labeler DUNS
- 011005491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7b77a682-ef86-4759-99ef-7716d118aa4c
Device Description
Pediatric Intermittent Catheter, Coude-tip
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
- 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 |
|---|---|---|---|---|
| GBM | Catheter, Urethral | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45605 | Single-administration urethral catheterization kit, single-use | A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20851593006252 | GS1 | 12 | In Commercial Distribution | ||
| Package | 10851593006255 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 00851593006258 | GS1 |
Customer Contacts
- Phone
- 770-788-0763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111405 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; Keep away from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage temperature not to exceed 120 degrees Fahrenheit