FDA.reportPublic FDA data

NA

Primary DI
07613252085515
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
89123
Catalog number
89123
Device description
Natural-Iris Conformer Color #4 Small
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQNCONFORMER, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQNConformer, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972034000MEDPOR OCULAR CONFORMERPorex Surgical, Inc.1998-01-20HQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252085515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252085515076132520855157613252085515

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic conformerAn ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20Millimeter
Width24Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08
04546540143273NA01-1973001-197302016-12-08
04546540166623NA09-0146109-014612017-01-11
04546540166630NA09-0146209-014622017-01-11
04546540215161NA37-1027237-102722016-12-08
04546540215222NA37-1041137-104112016-12-08
04546540215291NA37-1093037-109302016-12-08
04546540215413NA37-1246137-124612016-12-08
04546540217059NA41-3679241-367922016-12-08
04546540217066NA41-3679341-367932016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
CONFV2628Soper Brothers CustomSoper Brothers, IncorporatedHQN2026-03-03
00860015162823Dallas Eye ProstheticsDallas Eye ProstheticsHQN2025-12-23
G568V2628Ophthalmic ConformerTHOMPSON OCULAR PROSTHETICS, INC.HQN2025-03-10
B796V2628Ophthalmic ConformerMIDWEST EYE LABORATORIES, INC.HQN2024-03-28
G519V2628Ophthalmic ConformerMidwest Eye Laboratories Sioux Falls, LLCHQN2024-03-10
G290V2628Ophthalmic ConformerMidwest Eye Laboratories Woodbury, LLCHQN2024-02-20
G542V26280Ophthalmic ConformerTHE EYE CONCERN, INC.HQN2024-01-10
G521V2628Ophthalmic ConformerLegrand AssociatesHQN2023-10-18
00854428006195Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006201Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006218Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006348Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006355Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006362Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
10697660001002Bilateral Conformers 22 Extra-SmallOculo-Plastik IncHQN2021-06-08
13700773724908SYMBLEPHARON RING 25 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724915SYMBLEPHARON RING 20 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724922SYMBLEPHARON RING 22 MMFCI S A S FCI 20 22HQN2021-05-30
03760087122589SILICONE CONFORMER (FLEXIBLE)FCI S A S FCI 20 22HQN2021-05-30
B863E661090V2628Ophthalmic ConformerTEXAS EYE PROSTHETICS LLCHQN2020-04-14
03760087122732Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122749Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122756Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
10697660002344Symblepharon Ring Conformer SmallOculo-Plastik IncHQN2019-10-23
10697660002368Symblepharon Ring Conformer MediumOculo-Plastik IncHQN2019-10-23
10697660002382Symblepharon Ring Conformer LargeOculo-Plastik IncHQN2019-10-23
10697660001132Bilateral Conformer 18 SmallOculo-Plastik IncHQN2019-10-21
10697660001194Bilateral Conformer 16 RegularOculo-Plastik IncHQN2019-10-21
10697660001095Bilateral Conformer 18/20 SmallOculo-Plastik IncHQN2019-10-21
10697660001118Bilateral Conformer 18/20 RegularOculo-Plastik IncHQN2019-10-21