FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158218185
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
69127-01
Device description
"SPECULUM SAWYER RECTAL 2.5""X7/8"" BLADE 9.75"""
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXESpeculum, Non-Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158218185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158218185008101582181858101582181850810158218185

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
00810158210615PRINCETON03340-152026-07-10
00810158211193PRINCETON19150-042026-07-10
00810158215917PRINCETON43583-072026-07-10
00810158219861PRINCETON19995-222026-07-10
00810158219960PRINCETON45206-142026-07-10
00810158219977PRINCETON11320-252026-07-10
00810158219991PRINCETON44420-092026-07-10
00850088713008PRINCETON11103-142026-07-10
00850088713015PRINCETON03340-302026-07-10
00850088713022PRINCETON09283-182026-07-10
00850088713039PRINCETON03500-382026-07-10
00850088713046PRINCETON03500-422026-07-10
00850088713053PRINCETON03500-452026-07-10
00850088713060PRINCETON09980-112026-07-10
00850088713077PRINCETON09970-182026-07-10
00850088713084PRINCETON10010-192026-07-10
00850088713091PRINCETON10013-192026-07-10
00810158210837PRINCETON11180-152026-06-23
00810158211100PRINCETON13224-122026-06-23
00810158211117PRINCETON13245-142026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158218888PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218178PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00810158214699PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00192896100671TEALES GORGET SPECULUMSONTEC INSTRUMENTS, INC.FXE2025-02-24
00190776390167MillenniumAvalign Technologies, Inc.FXE2024-05-31
G586N6867570Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867580Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867590Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867610Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
00190776041786AvalignAvalign Technologies, Inc.FXE2023-11-13
00192896115750Teales Gorget SpeculumSONTEC INSTRUMENTS, INC.FXE2023-11-03
00190776316471MILLENNIUMAvalign Technologies, Inc.FXE2023-09-28
G453333611190PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
G4533336204900PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
00842962137956HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137963HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137970HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962119150HNM MEDICALHNM STAINLESS, LLC.FXE2023-03-30
14026704792211PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
14026704792228PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792219PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792226PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
00842331180996Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14