AccessGUDID - DEVICE: BAERVELDT GLAUCOMA IMPLANT (250) (05050474513013)

GUDID

Device Identifier (DI) Information

Brand Name: BAERVELDT GLAUCOMA IMPLANT (250)
Version or Model: BG103250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23030819
Company Name: ABBOTT MEDICAL OPTICS INC.

Primary DI Number: 05050474513013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103021940 *Terms of Use

Device Description: GLAUCOMA IMPLANT BG103-250 GLOBAL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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.

FDA Product Code

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Product Code	Product Code Name
KYF	IMPLANT, EYE VALVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Area/Surface Area: 250 Square millimeter

Device Record Status

Public Device Record Key: 7fb25b9e-e130-4909-b7ea-807ff03326f1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2015