DEVICE: CoRoent (00887517273895)

Device Identifier (DI) Information

CoRoent
6006855
In Commercial Distribution

Nuvasive, Inc.
00887517273895
GS1

1
053950783 *Terms of Use
CoRoent® XL+, 6x18x55mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Chicken pox anti-itch dressing A non-sterile substance designed to be topically applied to skin affected by chicken pox (Varicella zoster) lesions to provide a cooling effect and reduce the itching associated with chicken pox. It typically consists of an aqueous gel (hydrogel) intended to draw water to the skin surface through osmosis to facilitate skin cooling by water evaporation. It is normally available [non-prescription] over-the-counter (OTC) and may be used in healthcare facilities or in the home. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081611 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

e7ddab91-6d1a-4126-b15f-6a5ef8e31e43
July 06, 2018
3
October 26, 2016
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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
No
No CLOSE

Customer Contact

[?]
+1(858)909-1800
RA_UDI@nuvasive.com
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