LA Liner, Cushion, Uniform, 9mm, Large
- Primary DI
- 00614464181559
- Brand
- LA Liner, Cushion, Uniform, 9mm, Large
- Company
- Silipos Holding LLC
- Model
- 18155
- Published
- 2022-08-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| IPM | Cover, Limb |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IPM | Cover, Limb | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00614464181559 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| External limb prosthesis socket liner | A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane). |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 056112948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00614464040115 | Softzone Insole, 3/4 Length, Medium, 1pair/box | 4011 | 2022-08-24 | |
| 00614464040122 | Softzone Insole, 3/4 Length, Large, 1pair/box | 4012 | 2022-08-24 | |
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| 00614464040146 | Softzone Full Length Insole, Medium, 1pair/box | 4014 | 2022-08-24 | |
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