AccessGUDID - DEVICE: Endo Optiks® (30886158016077)

GUDID

Device Identifier (DI) Information

Brand Name: Endo Optiks®
Version or Model: OME200LA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158016077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: 20 Gauge Endoscope

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44932	Rigid optical ophthalmic endoscope	An endoscope with a rigid inserted portion intended for the observation and treatment of the eyeball and related structures. It is inserted into the eye during procedures such as endoscopic vitreoretinal surgery and glaucoma/cataract surgery. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Some endoscopes have a working channel to convey an instrument for procedures. It is typically used for observation of the retina, pars plana, posterior part of the iris, or angle of iris (angulus iridocornealis). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQP	Unit, cautery, thermal, battery-powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K910532	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be384527-7704-4c3c-b471-7c307f6f6d59
Public Version Date: November 17, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2016

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
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)906-8080
Email: customersupport@beaver-visitec.com

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