FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158218000
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
71420-13
Device description
UTERINE DILATOR HEGAR DOUBLE ENDED 13/14MMØ
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158218000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158218000008101582180008101582180000810158218000

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012857277
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810158210837PRINCETON11180-152026-06-23
00810158211100PRINCETON13224-122026-06-23
00810158211117PRINCETON13245-142026-06-23
00810158211148PRINCETON13220-142026-06-23
00810158211179PRINCETON69458-102026-06-23
00810158211186PRINCETON11140-162026-06-23
00810158211216PRINCETON61179-182026-06-23
00810158211223PRINCETON13257-142026-06-23
00810158211254PRINCETON09170-152026-06-23
00810158211285PRINCETON09491-162026-06-23
00810158211292PRINCETON19620-072026-06-23
00810158211360PRINCETON71115-032026-06-23
00810158216136PRINCETON41069-202026-06-23
00810158216594PRINCETON47124-90S2026-06-23
00810158219762PRINCETON11116-182026-05-20
00810158219779PRINCETON19995-382026-05-20
00810158219786PRINCETON89139-172026-05-20
00810158219793PRINCETON33654-102026-05-20
00810158219809PRINCETON45206-162026-05-20
00810158219816PRINCETON47471-042026-05-20

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Primary DI, Brand, Company table
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00348783011289Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
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07898506815050QuinelatoSchobell Industrial LtdaHDQ2023-01-09
07899798202634SchobellSchobell Industrial LtdaHDQ2023-01-09
10381780500728Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
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