DEVICE: SPOTLIGHT (10705034207728)

Device Identifier (DI) Information

SPOTLIGHT
282927540
In Commercial Distribution
282927540
DEPUY SPINE, LLC
10705034207728
GS1

1
107105876 *Terms of Use
SPOTLIGHT ACCESS SYSTEM ILLUMINATED ANATOMIC PORT 27 x 40mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Endoscopic light source, line-powered A mains electricity (AC-powered) device that provides light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes, e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes. It provides a source of bright light [e.g., typically using a xenon (Xe) light bulb] that is channelled via a light cable connecting this device to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating.
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FDA Product Code

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Product Code Product Code Name
GZT RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062814 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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 Record Status

2a49fb26-0db0-4d0c-8dce-d66f9aee685e
July 06, 2018
3
June 30, 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)

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

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Yes
No
No
No
No CLOSE

Customer Contact

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+1(800)255-2500
xx@xx.xx
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