DEVICE: BAERVELDT GLAUCOMA IMPLANT (350) (05050474512993)

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Device Identifier (DI) Information

BAERVELDT GLAUCOMA IMPLANT (350)
BG101350
23030817
ABBOTT MEDICAL OPTICS INC.
05050474512993
GS1
1
GLAUCOMA IMPLANT BG101-350 GLOBAL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Glaucoma shunt A sterile, 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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FDA Product Code

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Product Code Product Code Name
KYF IMPLANT, EYE VALVE
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Area/Surface Area: 350 Square millimeter
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Device Status

In Commercial Distribution
September 15, 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)

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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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+1(877)266-4543
SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
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