FDA.reportPublic FDA data

Intrace USA

Primary DI
00850090726157
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
INT-DNT-MXF-029-002
Catalog number
INT-DNT-MXF-029-002
Device description
Buser Periosteal Elevator, Double-Ended, 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
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850090726157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850090726157008500907261578500907261570850090726157

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
00850090726201Intrace USAINT-DNT-IMP-041INT-DNT-IMP-0412026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850090726270Intrace USAPILOTIS TECH LLCEMJ2026-10-31
00850090726317Intrace USAPILOTIS TECH LLCEMJ2026-10-31
00850090726324Intrace USAPILOTIS TECH LLCEMJ2026-10-31
00850090726331Intrace USAPILOTIS TECH LLCEMJ2026-10-31
00190776439842MilleniumAvalign Technologies, Inc.EMJ2026-10-29
00190776434274MillenniumAvalign Technologies, Inc.EMJ2026-10-06
G8791028230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G8791034180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G8791060520DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G879LX3CFG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G879LX3DCG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
D955BDT11Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT21Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT31Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT61Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT71Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT81Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT91Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE461Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE571Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE581Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE77RW1Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
G879LXB50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-25
G879103420TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879106049TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061170DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879101067S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13