FDA.reportPublic FDA data

Intrace USA

Primary DI
00860015282064
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
D30-1080
Catalog number
D30-1080
Device description
Gills Chalazion Curette, typically 12cm-13cm Overall Length, Small Oval/Round Cup Tip, Stainless Steel, Reusable
Published
2026-07-03
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
HNZCurette, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015282064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015282064008600152820648600152820640860015282064

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, reusableA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6124230756info@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
00850083275006Intrace USA03-004-14003-004-1402026-07-03
00850083275013Intrace USA03-022-14003-022-1402026-07-03
00850083275037Intrace USA03-097-14503-097-1452026-07-03
00850083275044Intrace USA70-10-2570-10-252026-07-03
00850083275051Intrace USA03-182-11003-182-1102026-07-03
00850083275068Intrace USA03-316-13003-316-1302026-07-03
00850083275075Intrace USA04-002-09004-002-0902026-07-03
00850083275082Intrace USA04-012-12504-012-1252026-07-03
00850083275099Intrace USA04-029-16004-029-1602026-07-03
00850083275105Intrace USA04-030-14004-030-1402026-07-03
00850083275112Intrace USA04-056-20004-056-2002026-07-03
00850083275129Intrace USA04-070-18004-070-1802026-07-03
00850083275136Intrace USA04-082-16004-082-1602026-07-03
00850083275143Intrace USA04-214-18004-214-1802026-07-03
00850083275150Intrace USA04-240-13004-240-1302026-07-03
00850083275167Intrace USA04-273-26004-273-2602026-07-03
00850083275174Intrace USA05-004-14505-004-1452026-07-03
00850083275181Intrace USA05-011-11505-011-1152026-07-03
00850083275198Intrace USA05-013-14505-013-1452026-07-03
00850083275204Intrace USA05-087-15505-087-1552026-07-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770505708Bausch + LombBausch & Lomb IncorporatedHNZ2026-04-30
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00190776410780MillenniumAvalign Technologies, Inc.HNZ2025-09-12
00757770636242Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-13
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNZ2025-08-11
00757770407583Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415199Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415533Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419029Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419401Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770433636Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770436385Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00194613005160MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613087142MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613100377MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101558MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
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00194613108588MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613113988MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
04058935012663Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012670Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012687Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012694Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012700Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012717Skeele CuretteBausch & Lomb GmbHHNZ2025-07-10
G412PH62530MR PHACOCrestpoint Management LimitedHNZ2025-06-09
00194613005153MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-03-21
00194613021542MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-03-21
00757770523443Bausch + LombBausch & Lomb IncorporatedHNZ2024-11-20