FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158212589
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
49695-02
Device description
"SPLIT SEPARATORS SMITH SAGITTAL LEFT 9MM 7.25"""
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158212589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158212589008101582125898101582125890810158212589

GMDN Terms#

Term, Definition table
TermDefinition
Maxillofacial bone separatorA hand-held, manual, one-piece surgical instrument intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during maxillofacial surgery (e.g., sagittal split osteotomy procedure); it is not designed to cut or shape bone (i.e., not an osteotome). It is a metal instrument typically available as: 1) a curved shaft with a handle and a blade at the distal working end; or 2) a hinged device with two blades at the distal working end and a spring handle. 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
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
00810135963169ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963183ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963251ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962889TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962896TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962902TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962919TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962926TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962933TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135963435TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810005668040Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963046Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963053Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963060Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963077Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963084Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963091Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963107Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
00810135962667TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27