FDA UDI
In Commercial Distribution
🇺🇸 United States
Meicen
DI: 06977071937501
·
Model: /
·
Guangdong Meicen Medical Equipment Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Meicen
- Primary DI
- 06977071937501
- Version / Model
- /
- Company Name
- Guangdong Meicen Medical Equipment Co., Ltd.
- Labeler DUNS
- 724689169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- 7bcdad59-0be3-4b06-8cb2-36dfdf56a273
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | 878.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58755 | Arm splint system, thermoplastic | An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied around the upper limb of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the limb and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient’s arm. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06977071937501 | GS1 |