FDA UDI
In Commercial Distribution
🇺🇸 United States
Slide.fit
DI: 04048817590150
·
Model: 17A1/XXL
·
Streifeneder ortho.production GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Slide.fit
- Primary DI
- 04048817590150
- Version / Model
- 17A1/XXL
- Catalog Number
- 17A1/XXL
- Company Name
- Streifeneder ortho.production GmbH
- Labeler DUNS
- 317931954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-02
- Public Version
- 1
- Public Version Date
- 2020-11-10
- Public Version Status
- New
- Public Device Record Key
- 6ed0e763-df17-47f4-b96c-6fd0218e394b
Device Description
donning aid for transfemoral prostheses, size XXL, dark grey / orange
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ISY | Joint, Knee, External Limb Component | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64718 | Mechanical-resistance external knee prosthesis | A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for device stance/swing control is based on media-free mechanical resistance (i.e., mechanical friction/spring-actuation with no fluid or gas operating media). The device may have various designs and functional features (e.g., hinge-type, spring-control, monocentric or polycentric, semi-automatic or manual lock/brake) for support during a variety of activities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048817590150 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | size S: length 50 cm, dark grey / red, residual limb circumference distal up to 26 cm, proximal up to 44 cm | ||
| Device Size Text, specify | size M: length 50 cm, dark grey / dark blue, residual limb circumference distal up to 28 cm, proximal up to 56 cm | ||
| Device Size Text, specify | size L: length 50 cm, dark grey / green, residual limb circumference distal up to 30 cm, proximal up to 68 cm | ||
| Device Size Text, specify | size XL: length 52 cm, dark grey / light blue, residual limb circumference distal up to 36 cm, proximal up to 76 cm | ||
| Device Size Text, specify | size XXL: length 60 cm, dark grey / orange, residual limb circumference distal up to 38 cm, proximal up to 88 cm | ||
| Device Size Text, specify | size XS: length 43 cm, dark grey / yellow, residual limb circumference distal up to 24 cm, proximal up to 40 cm |