FDA.reportPublic FDA data

Intrace USA

Primary DI
00850090726201
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
INT-DNT-IMP-041
Catalog number
INT-DNT-IMP-041
Device description
LiftTrace Ogeechee — Dissector, 145 mm Length, 2.2 mm x 0.7 mm Tip, Stainless Steel, Reusable.
Published
2026-10-31
Public version status
New
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850090726201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850090726201008500907262018500907262010850090726201

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4049196896info@intrace.us

Regulatory Flags#

DUNS number
110680677
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
00850090726003Intrace USAINT-SRG-ENT-145-002INT-SRG-ENT-145-0022026-10-31
00850090726010Intrace USAINT-SRG-ENT-145-001INT-SRG-ENT-145-0012026-10-31
00850090726027Intrace USAINT-SRG-ENT-145-003INT-SRG-ENT-145-0032026-10-31
00850090726034Intrace USAINT-DNT-EXT-004-004INT-DNT-EXT-004-0042026-10-31
00850090726041Intrace USAINT-DNT-EXT-004-003INT-DNT-EXT-004-0032026-10-31
00850090726058Intrace USAINT-DNT-DPR-106-002INT-DNT-DPR-106-0022026-10-31
00850090726065Intrace USAINT-DNT-DPR-106-001INT-DNT-DPR-106-0012026-10-31
00850090726072Intrace USAINT-SRG-GYN-206-003INT-SRG-GYN-206-0032026-10-31
00850090726089Intrace USAINT-DNT-EXT-009-003INT-DNT-EXT-009-0032026-10-31
00850090726096Intrace USAINT-DNT-MXF-097INT-DNT-MXF-0972026-10-31
00850090726102Intrace USAINT-DNT-DPR-160-002INT-DNT-DPR-160-0022026-10-31
00850090726119Intrace USAINT-DNT-DPR-160-001INT-DNT-DPR-160-0012026-10-31
00850090726126Intrace USAINT-DNT-MXF-163-002INT-DNT-MXF-163-0022026-10-31
00850090726133Intrace USAINT-DNT-DPR-207INT-DNT-DPR-2072026-10-31
00850090726140Intrace USAINT-DNT-DPR-206INT-DNT-DPR-2062026-10-31
00850090726157Intrace USAINT-DNT-MXF-029-002INT-DNT-MXF-029-0022026-10-31
00850090726164Intrace USAINT-SRG-OPH-062-003INT-SRG-OPH-062-0032026-10-31
00850090726171Intrace USAINT-SRG-OPH-062-004INT-SRG-OPH-062-0042026-10-31
00850090726188Intrace USAINT-SRG-OPH-062-005INT-SRG-OPH-062-0052026-10-31
00850090726195Intrace USAINT-SRG-OPH-062-006INT-SRG-OPH-062-0062026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435363MillenniumAvalign Technologies, Inc.GDI2026-10-19
00190776433765MillenniumAvalign Technologies, Inc.GDI2026-10-08
00190776433758MillenniumAvalign Technologies, Inc.GDI2026-10-07
G141530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805410Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805420Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14167216050Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G1415530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-09-30
00190776432461MillenniumAvalign Technologies, Inc.GDI2026-09-24
G4533310930PEAK MEDICALPeak Medical Distribution Inc.GDI2026-08-27
00190776419110MillenniumAvalign Technologies, Inc.GDI2026-08-23
00840217910286Wiggins MedicalEBNER MEDICAL, LLCGDI2026-08-13
00190776424367MillenniumAvalign Technologies, Inc.GDI2026-08-07
00190776408626MillenniumAvalign Technologies, Inc.GDI2026-08-03
B382SD914709040Surgical DirectSurgical Direct, Inc.GDI2026-07-29
00810068850765Biocore9 Acetabular Bearing SystemBiocore9, LLCGDI2026-06-26
07898789390121ENDOFOREHEAD DISSECTOR 5MM ANGLEDTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390138ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00840217909570Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909587Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909358Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909365Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909372Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909389Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06