FDA.reportPublic FDA data

Intrace USA

Primary DI
00850083275433
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
14-238-001
Catalog number
14-238-001
Device description
Hegar Uterine Dilator Set, 8 Double-Ended Pieces, Range 3/4 mm to 17/18 mm, 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
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083275433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083275433008500832754338500832754330850083275433

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

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
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
00850083275457Intrace USAPILOTIS TECH LLCFFP2026-07-03
00850005838449Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838456Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838463Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838487Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838494Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
G586UR6213360Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
00842331194603Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216100Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216160Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217150Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217210Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217220Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217230Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217240Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
08033638801147DilastomSAPI MED SPAFFP2023-08-02