FDA.reportPublic FDA data

Intrace USA

Primary DI
00850090726096
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
INT-DNT-MXF-097
Catalog number
INT-DNT-MXF-097
Device description
Lucas Surgical Bone Curette, Fig. 88, Double-Ended, Serrated, Hollow Handle, 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
EMKCurette, Surgical, Dental

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850090726096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850090726096008500907260968500907260960850090726096

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD915584140Surgical DirectSurgical Direct, Inc.EMK2026-10-30
B382SD9146381000Surgical DirectSurgical Direct, Inc.EMK2026-10-28
B382SD9146381010Surgical DirectSurgical Direct, Inc.EMK2026-10-28
00724995267933Snowden-PencerSTERIS Deutschland GmbHEMK2026-10-15
B382SD914603200Surgical DirectSurgical Direct, Inc.EMK2026-10-15
B382SD920761000Surgical DirectSurgical Direct, Inc.EMK2026-10-15
B382SD914636200Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636210Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636230Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636240Surgical DirectSurgical Direct, Inc.EMK2026-10-09
G8791021780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102178H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
B382SD9213571010Surgical DirectSurgical Direct, Inc.EMK2026-08-07