FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158219601
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
45722-25
Device description
"HOOKLET SHAMBAUGH 2.5MM 45° ANGLE 6.25"""
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158219601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158219601008101582196018101582196010810158219601

GMDN Terms#

Term, Definition table
TermDefinition
Eye muscle hook, reusableA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. 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
00850088713176PRINCETON19219-152026-07-23
00850088713183PRINCETON13251-182026-07-23
00850088713190PRINCETON33729-072026-07-23
00850088713206PRINCETON34118-312026-07-23
00850088713213PRINCETON69115-152026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30