FDA.reportPublic FDA data

Intrace USA

Primary DI
00850083275419
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
14-139-310
Catalog number
14-139-310
Device description
Recamier Uterine Curette, Sharp Loop, Rigid or Malleable Shaft, 31 cm Length, 5 mm Tip Width, 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
HGCClamp, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGCClamp, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083275419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083275419008500832754198500832754190850083275419

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275167Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275327Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275389Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275396Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275402Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275426Intrace USAPILOTIS TECH LLCHGC2026-07-03
00190776410698MillenniumAvalign Technologies, Inc.HGC2025-09-12
00190776405311MillenniumAvalign Technologies, Inc.HGC2025-07-15
00190776399818MillenniumAvalign Technologies, Inc.HGC2025-06-02
G586OB2791320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB2792320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300700Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300710Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300720Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300730Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300740Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300750Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300760Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300770Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300780Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300790Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300820Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300830Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300860Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300910Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300920Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300930Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300940Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300950Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6356310Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18