DEVICE: Integra® (10381780505891)
Device Identifier (DI) Information
Integra®
000099
Not in Commercial Distribution
000099
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
000099
Not in Commercial Distribution
000099
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Holder Mirror Assembly With Shield
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
32037 | General-purpose light source |
A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FCW | Light source, fiberoptic, routine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9bedeadd-663d-4891-91bb-adcd15b38435
March 10, 2023
3
September 12, 2018
March 10, 2023
3
September 12, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | H8340000990 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com