FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Medical Specialties, Inc.
DI: 00815849020207
·
Model: CMS-608
·
CUSTOM ASSEMBLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Custom Medical Specialties, Inc.
- Primary DI
- 00815849020207
- Version / Model
- CMS-608
- Company Name
- CUSTOM ASSEMBLIES, INC.
- Labeler DUNS
- 948904735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-09
- Public Version
- 3
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 2ce78374-6119-4ab2-806b-631b37a597f9
Device Description
8mm Reducer Plug - Non-Sterile
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NVT | Tubing And Tubing/Filter Fits | Obstetrics/Gynecology | 884.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45389 | Closed-wound drain connector | A tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815849020771 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00815849020207 | GS1 |