FDA UDI
In Commercial Distribution
🇺🇸 United States
Contodo Medicsl Supplies
DI: 00860013348786
·
Model: CTMS0007
·
Contodo LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
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Basic Information
- Brand Name
- Contodo Medicsl Supplies
- Primary DI
- 00860013348786
- Version / Model
- CTMS0007
- Company Name
- Contodo LLC
- Labeler DUNS
- 127598607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2025-03-13
- Public Version
- 1
- Public Version Date
- 2025-03-21
- Public Version Status
- New
- Public Device Record Key
- dda8298e-ef97-4bea-8419-2bc7207fe6a9
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FYA | Gown, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61938 | Surgical/examination garment kit | A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10860013348707 | GS1 | ||||
| Primary | 00860013348786 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212718 | 000 |