DEVICE: Slide.fit (04048817590136)

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Device Record History
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Device Identifier (DI) Information
Slide.fit
17A1/L
In Commercial Distribution
17A1/L
Streifeneder ortho.production GmbH
04048817590136
GS1

1
317931954 *Terms of Use
donning aid for transfemoral prostheses, size L, dark grey / green
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ISY Joint, Knee, External Limb Component
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type 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
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Device Record Status
308d6415-a738-46d8-9904-e5d15ad55466
November 10, 2020
1
November 02, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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