DEVICE: BAERVELDT GLAUCOMA IMPLANT (350) (05050474512993)
Device Identifier (DI) Information
BAERVELDT GLAUCOMA IMPLANT (350)
BG101350
In Commercial Distribution
23030817
JOHNSON & JOHNSON SURGICAL VISION, INC.
BG101350
In Commercial Distribution
23030817
JOHNSON & JOHNSON SURGICAL VISION, INC.
GLAUCOMA IMPLANT BG101-350 GLOBAL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
61127 | Glaucoma shunt |
A non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KYF | IMPLANT, EYE VALVE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Area/Surface Area: 350 Square millimeter |
Device Record Status
fab4b575-e932-47d5-8c4c-085d601646e4
August 24, 2021
5
September 15, 2015
August 24, 2021
5
September 15, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
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(877)266-4543
JJV-US-SURGICALORDERS@ITS.JNJ.COM
JJV-US-SURGICALORDERS@ITS.JNJ.COM