FDA UDI
In Commercial Distribution
🇺🇸 United States
ContexGel.sleeve
DI: 04048817622752
·
Model: 30L50/XL
·
Streifeneder ortho.production GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ContexGel.sleeve
- Primary DI
- 04048817622752
- Version / Model
- 30L50/XL
- Catalog Number
- 30L50/XL
- Company Name
- Streifeneder ortho.production GmbH
- Labeler DUNS
- 317931954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-03
- Public Version
- 1
- Public Version Date
- 2020-11-11
- Public Version Status
- New
- Public Device Record Key
- 3353138b-e433-4009-b47b-6cbf9d0a2e17
Device Description
ContexGel.sleeve, sand-coloured, knee sleeve, size XL, length: 38,5 cm, one-piece knit cover, antibacterial finish
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ISS | Prosthesis, Thigh Socket, External Component | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41536 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048817622752 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm | ||
| Device Size Text, specify | 30L50/M: size M, length: 37 cm, dist.: 21-31 cm, prox.: 29-44 cm | ||
| Device Size Text, specify | 30L50/L: size L, length: 38,5 cm, dist.: 28-43 cm, prox.: 36-52 cm | ||
| Device Size Text, specify | 30L50/XL: size XL, length: 38,5 cm, dist.: 34-48 cm, prox.: 42-58 cm | ||
| Device Size Text, specify | 30L50/XXL: size XXL, length: 38,5 cm, dist.: 38-52 cm, prox.: 43-64 cm |