FDA UDI
In Commercial Distribution
🇺🇸 United States
4Med
DI: 07290018281123
·
Model: 9910102-35
·
4 MED LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 4Med
- Primary DI
- 07290018281123
- Version / Model
- 9910102-35
- Company Name
- 4 MED LTD
- Labeler DUNS
- 532201977
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-27
- Public Version
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 6db4a456-ce01-4353-b1e6-298ed0e47109
Device Description
Skin Graft Carrier 35 cm
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEJ | Carrier, Ligature | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47924 | Skin graft carrier | A sterile device in the form of a flat, rectangular plate designed to support a skin graft (a section of donor skin from another part of a patient's body) while the graft is being perforated in a skin graft mesher in preparation for grafting to the treatment site. It is typically made of disposable plastic material. The carrier is also used to transfer the perforated graft from the mesher to the grafting site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290018281130 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 07290018281123 | GS1 |
Customer Contacts
- Phone
- +97286805223
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity