DEVICE: Restylane Sub-Q (05060457760167)

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Device Identifier (DI) Information

Restylane Sub-Q
110635

LAMBSMEAD LTD
05060457760167
GS1
1
No description.
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Device Characteristics

MR Safe
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dermal tissue reconstructive material, animal-derived A sterile, bioabsorbable, animal-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), to correct cutaneous contour deformities (e.g., scars) associated with aging, injury, or degenerative lesions; it may in addition be used as a bulking material for incontinence treatment (e.g., in the urinary tract). It does not include a local anaesthetic agent. It includes animal-derived collagen or hyaluronic acid (HA) [e.g., porcine, bovine]. It is typically preloaded in a disposable syringe.
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FDA Product Code

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Product Code Product Code Name
LMH Implant, Dermal, For Aesthetic Use
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 24, 2015

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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)

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

[?]
Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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