FDA UDI
In Commercial Distribution
🇺🇸 United States
Mediflex
DI: 08904332600629
·
Model: 412FB-2
·
ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Mediflex
- Primary DI
- 08904332600629
- Version / Model
- 412FB-2
- Company Name
- ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
- Labeler DUNS
- 872346468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-05-13
- Public Version
- 1
- Public Version Date
- 2025-05-21
- Public Version Status
- New
- Public Device Record Key
- 3430015c-55da-47f7-8d45-719a0135eca6
Device Description
SureStay Elastic Beaded Stays 12mm, Two finger Blunt Hook 2 per pack / Skin Hook, Blunt 2-fingers, Moulded 2 per pack
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47821 | Surgical retractor/retraction system blade, single-use | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904332600674 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 08904332600629 | GS1 | ||||
| Unit of Use | 08904332600575 | GS1 |