FDA.reportPublic FDA data

VersiTomic ACL/PCL Sterilization Tray

Primary DI
10810190013080
Brand
VersiTomic ACL/PCL Sterilization Tray
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C
Catalog number
tg20130st
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100887000VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAYTag Medical Products2010-08-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810190013080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001308010810190013080

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128461518CARTIHEAL AGILI-C Disposable Toolset 12.5CHDT-125340125sn2025-08-05
10810128464144Tendon Stripper, Closed168210BSM168210bsm2026-10-20
10810128464151Tendon Stripper, Open168200BSM168200bsm2026-10-20
10810128464168Tunnel Depth Probe138200BSM138200bsm2026-10-20
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm234-109-105145105st2026-08-03
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm234-113-110124110st2026-08-03
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmTHN00720134070oss2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmTHN00721134100oss2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmTHN00685134070-01oss2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmTHN00684134100-01oss2026-08-23
10810128464311Hip 2.5 Grasper393400t393400t2026-03-19
10818674024324Hip Bone Pick 60°512404t512404t2026-03-19
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147988ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148015ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148237ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148336ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148343ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148350ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147452ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147469ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147476ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147353ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536147414ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148022ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148312ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
00841536148480ThompsonThompson Surgical Instruments, Inc.KCT2026-08-12
00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08