DEVICE: Restylane Silk-L (07331689113952)

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Device Record History
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Device Identifier (DI) Information
Restylane Silk-L
1.0 ml syringe - demo
In Commercial Distribution

Q-Med AB
07331689113952
GS1

1
355371873 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
47887 Dermal tissue reconstructive material, microbe-derived, anaesthetic
A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LMH Implant, Dermal, For Aesthetic Use
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P040024 072
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not expose to direct sunlight
Special Storage Condition, Specify: Do not freeze
Special Storage Condition, Specify: Refrigeration not required
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
1636604a-72c6-4ed2-acb0-8f122b04552d
July 06, 2018
3
June 13, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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