FDA.reportPublic FDA data

TriLEAP

Primary DI
00810112592726
Brand
TriLEAP
Company
Synthes GmbH
Model
03.900.324
Catalog number
03900324
Device description
TriLEAP(TM) Small Ratchet Handle W/ Quick Coupling
Published
2024-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112592726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112592726008101125927268101125927260810112592726

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
480426451
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592986TriLEAP04.901.022049010222024-02-22
00810112592993TriLEAP04.901.024049010242024-02-22
00810112593006TriLEAP04.901.026049010262024-02-22
00810112593013TriLEAP04.901.028049010282024-02-22
00810112593020TriLEAP04.901.030049010302024-02-22
00810112593037TriLEAP04.902.008049020082024-02-22
00810112593044TriLEAP04.902.009049020092024-02-22
00810112593051TriLEAP04.902.010049020102024-02-22
00810112593068TriLEAP04.902.011049020112024-02-22
00810112593075TriLEAP04.902.012049020122024-02-22
00810112593082TriLEAP04.902.013049020132024-02-22
00810112593099TriLEAP04.902.014049020142024-02-22
00810112593105TriLEAP04.902.015049020152024-02-22
00810112593112TriLEAP04.902.016049020162024-02-22
00810112593129TriLEAP04.902.018049020182024-02-22
00810112593136TriLEAP04.902.020049020202024-02-22
00810112593143TriLEAP04.902.022049020222024-02-22
00810112593150TriLEAP04.902.024049020242024-02-22
00810112593167TriLEAP04.902.026049020262024-02-22
00810112593174TriLEAP04.902.028049020282024-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02
07630894822582APTUSMedartis AGLXH2026-11-02
07630894822599APTUSMedartis AGLXH2026-11-02
07630894822629APTUSMedartis AGLXH2026-11-02
07630894822636APTUSMedartis AGLXH2026-11-02
07630894822643APTUSMedartis AGLXH2026-11-02
07630894822650APTUSMedartis AGLXH2026-11-02
07630894822681APTUSMedartis AGLXH2026-11-02
07630894823787APTUSMedartis AGLXH2026-11-02
00824846010746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00824846010753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00810017915446Pituitary Straight, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915453Pituitary Straight, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017915460Kerrison, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915477Kerrison, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017916085SABER-XA Angled Self-Retaining Driver, No. 20 HexalobeELEVATION SPINE, INC.LXH2026-10-30
00811382039348NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
03700569680121Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
03700569680138Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
B382SD9144842000Surgical DirectSurgical Direct, Inc.LXH2026-10-30