FDA.reportPublic FDA data

Intrace USA

Primary DI
00850090726058
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
INT-DNT-DPR-106-002
Catalog number
INT-DNT-DPR-106-002
Device description
Goldman-Fox Gum Scissors, Curved, Tungsten Carbide Inserts, 13 cm Length, 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
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850090726058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850090726058008500907260588500907260580850090726058

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850090726065Intrace USAPILOTIS TECH LLCEGN2026-10-31
00850090726164Intrace USAPILOTIS TECH LLCEGN2026-10-31
00850090726171Intrace USAPILOTIS TECH LLCEGN2026-10-31
00850090726188Intrace USAPILOTIS TECH LLCEGN2026-10-31
00850090726195Intrace USAPILOTIS TECH LLCEGN2026-10-31
B382SD92006332E0Surgical DirectSurgical Direct, Inc.EGN2026-10-30
B382SD92006357E0Surgical DirectSurgical Direct, Inc.EGN2026-10-30
E896115984210SCHWERTA. Schweickhardt GmbH & Co. KGEGN2026-10-22
B382SD62371520Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903223060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454040Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD9030741020Surgical DirectSurgical Direct, Inc.EGN2026-10-08
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103062TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30