FDA.reportPublic FDA data

TransLoc 3D

Primary DI
00850026642247
Brand
TransLoc 3D
Company
Foundation Fusion Solutions, LLC
Model
S1076-010
Device description
Tray Lid
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211496000TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)2022-07-27OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026642247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026642247008500266422478500266422470850026642247

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-743-8736bob@cornerloc.com

Regulatory Flags#

DUNS number
105361659
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026642179TransLoc 3D S24-092023-10-17
00850026642308TransLoc 3D TS85-602023-10-31
00850026642315TransLoc 3D TS95-352023-10-31
00850026642322TransLoc 3D TS95-402023-10-31
00850026642339TransLoc 3D TS95-452023-10-31
00850026642346TransLoc 3D TS95-502023-10-31
00850026642353TransLoc 3D TS95-552023-10-31
00850026642360TransLoc 3D TS95-602023-10-31
00850026642001TransLoc 3D T05-012023-10-17
00850026642018TransLoc 3D T05-022023-10-17
00850026642100TransLoc 3D S01-012023-10-17
00850026642117TransLoc 3D S01-022023-10-17
00850026642124TransLoc 3D S02-012023-10-17
00850026642131TransLoc 3D S03-012023-10-17
00850026642148TransLoc 3D S04-012023-10-17
00850026642155TransLoc 3D S06-012023-10-17
00850026642162TransLoc 3D S06-022023-10-17
00850026642193TransLoc 3D T01-022023-10-17
00850026642209TransLoc 3D T02-402023-10-17
00850026642216TransLoc 3D T03-012023-10-17

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00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
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