DEVICE: PeroSupport.tec (04048817620192)

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Device Record History
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Device Identifier (DI) Information
PeroSupport.tec
197R4/L0
In Commercial Distribution
197R4/L0
Streifeneder ortho.production GmbH
04048817620192
GS1

1
317931954 *Terms of Use
PeroSupport.tec, peroneal spring made of carbon-pre-preg, dynamic, with magnetic closure, shoe size: 34-36, left
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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?
36206 Ankle/foot orthosis
A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHI Orthosis, Foot Drop
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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: 197R4/L0: shoe size: 34-36, left, height 32,5 cm
Device Size Text, specify: 197R4/L1: shoe size: 36-39, left, height 33,5 cm
Device Size Text, specify: 197R4/L2: shoe size: 39-42, left, height 34,5 cm
Device Size Text, specify: 197R4/L3: shoe size: 42-45, left, height 35,5 cm
Device Size Text, specify: 197R4/L4: shoe size: 45-48, left, height 37,5 cm
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Device Record Status
ba9ff284-bacc-46a4-9bd7-cecd3b99b98f
June 10, 2022
3
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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