Artisan/Artiflex OD125A

GUDID 08717819049176

Enclavation Needles

Ophtec B.V.

Ocular hook/spatula/manipulator, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use Ophthalmic surgical probe, single-use
Primary Device ID08717819049176
NIH Device Record Keyd771ab9c-6080-4042-a86e-e611b66d6742
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtisan/Artiflex
Version Model NumberOD125A
Catalog NumberOD125A
Company DUNS405048120
Company NameOphtec B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com
Phone+31505251944
Emailinfo@ophtec.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment
Special Storage Condition, SpecifyBetween 0 and 0 *Shelf-packs should be stored in a dry, climate-controlled environment

Device Identifiers

Device Issuing AgencyDevice ID
GS108717819049176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRJRing, Endocapsular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2018-09-24

Devices Manufactured by Ophtec B.V.

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08717819047356 - Verisyse2021-07-08 Verisyse Myopia 5.0 mm -7.0D
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08717819047370 - Verisyse2021-07-08 Verisyse Myopia 5.0 mm -8.0D
08717819047387 - Verisyse2021-07-08 Verisyse Myopia 5.0 mm -8.5D
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