FDA.reportPublic FDA data

Oval Sponge

Primary DI
18713210001208
Brand
Oval Sponge
Company
Labtician Ophthalmics, Inc
Model
S 1981-7.5
Device description
Oval Sponge
Published
2018-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQXImplant, Orbital, Extra-Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQXImplant, Orbital, Extra-OcularOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875014000LABTICIAN RETINAL IMPLANTSLabtician Products, Inc.1988-02-26HQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18713210001208PrimaryGS10
08713210000044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1871321000120818713210001208
08713210000044087132100000448713210000044

GMDN Terms#

Term, Definition table
TermDefinition
Scleral buckling device, bioabsorbableA sterile, bioabsorbable device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-829-0055philcuscuna@labtician.com

Regulatory Flags#

DUNS number
248911026
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10871321002526LabVit KitLVK1000, LVK1100N/A2018-02-26
00871321000297Labtician Lid Load Adhesive StripsNST 400NST 4002018-08-07
10871321001369Grooved SpongeS 1983-3.22015-10-05
10871321001628Silicone Tire 10mmS 29772015-10-09
10871321001635Meridional Implant - FlatS 29782015-10-09
10871321001642Silicone Tire 7mmS 29862015-10-09
10871321001659Circling BandS 29872015-10-09
108713210016662.5mm Circling BandS 2987-M2018-02-22
10871321001673Meridional ImplantS 29882015-10-09
10871321001680BoatS 29892015-10-09
10871321001697Silicone Tire 9mmS 29912015-10-09
10871321001703Silicone StripS 29922015-10-09
108713210017102.5mm Grooved StripS 2992-M2018-02-22
10871321001727PadS 29932015-10-09
10871321001734Silicone Tire 6.0mmS 29942015-10-09
10871321001741Silicone Tire 8.5mmS 29952015-10-09
10871321001758Silicone Tire 10mmS 29962015-10-09
10871321001765Silicone Tire 10mm LGS 2996 L2015-10-09
10871321001772Silicone Tire 12.5mmS 29972015-10-09
10871321001789Silicone StripS 29982015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760087121971HALF-SPONGE 2.75 X 7.5 TYPE 511FCI S A S FCI 20 22HQX2021-05-30
33760087121972HALF-SPONGE 2.75 X 7.5 TYPE 511FCI S A S FCI 20 22HQX2021-05-30
08717872014487Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014555Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014661Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014484Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014552Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014668Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
03760087121179Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121186Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121193Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121216Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121230Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121247Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121254Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121292Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121308Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121391Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121421Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121438Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121452Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121520Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121537Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121544Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121551Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121803Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121810Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121827Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121872Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121896Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06