FDA.reportPublic FDA data

3.0mm Round Sponge

Primary DI
00871321000099
Brand
3.0mm Round Sponge
Company
Labtician Ophthalmics, Inc
Model
S 1982-3-M
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQJImplant, Absorbable, (Scleral Buckling Methods)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQJImplant, Absorbable, (Scleral Buckling Methods)Ophthalmic2

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
10871321001253PackageGS15In Commercial Distribution
00871321000099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087132100125310871321001253
00871321000099008713210000998713210000990871321000099

GMDN Terms#

Term, Definition table
TermDefinition
Scleral buckling device, non-bioabsorbableA non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

Contacts#

Phone, Email table
PhoneEmail
9058290055philcuscuna@labtician.com

Regulatory Flags#

DUNS number
248911026
Device count
1
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
00871321000013Oval SpongeS 1981-42026-10-01
00871321000020Oval SpongeS 1981-52026-10-01
00871321000044Oval SpongeS 1981-7.52026-10-01
00871321000051Round Sponge 1.5mmS 1982-1.52026-10-01
00871321000068Round Sponge 2mmS 1982-22026-10-01
00871321000075Round Sponge 2.5mmS 1982-2.52026-10-01
00871321000082Round Sponge 3mmS 1982-32026-10-01
00871321000105Round Sponge 4mmS 1982-42026-10-01
00871321000112Round Sponge 5mmS 1982-52026-10-01
008713210001295.0mm Round SpongeS 1982-5-M2026-10-01
00871321000136Round Tunnel Sponge 5mmS 1982-5T2026-10-01
00871321000143Round Sponge 7mmS 1982-72026-10-01
00871321000150Round Sponge 7.5mm x 50mmS 1982-7.52026-10-01
00871321000167Grooved SpongeS 1983-2.32026-10-01
00871321000174Grooved Part Thickness SpongeS 1983-2.52026-10-01
00871321000181Grooved Part Thickness SpongeS 1983-2.82026-10-01
00871321000198Grooved SpongeS 1983-32026-10-01
00871321000204Grooved SpongeS 1983-3.22026-10-01
00871321000211Grooved SpongeS 1983-3.52026-10-01
00871321000228Grooved SpongeS 1983-42026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00871321000013Oval SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000020Oval SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000044Oval SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000051Round Sponge 1.5mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000068Round Sponge 2mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000075Round Sponge 2.5mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000082Round Sponge 3mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000105Round Sponge 4mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000112Round Sponge 5mmLabtician Ophthalmics, IncHQJ2026-10-01
008713210001295.0mm Round SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000136Round Tunnel Sponge 5mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000143Round Sponge 7mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000150Round Sponge 7.5mm x 50mmLabtician Ophthalmics, IncHQJ2026-10-01
00871321000167Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000174Grooved Part Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000181Grooved Part Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000198Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000204Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000211Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000228Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000242Grooved SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000259Partial Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000266Partial Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000273Partial Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000280Partial Thickness SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000303Scholda Partial ThicknessLabtician Ophthalmics, IncHQJ2026-10-01
00871321000310Scholda Partial ThicknessLabtician Ophthalmics, IncHQJ2026-10-01
00871321000327Oblong SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000334Oblong SpongeLabtician Ophthalmics, IncHQJ2026-10-01
00871321000358Accessory SpongeLabtician Ophthalmics, IncHQJ2026-10-01