FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158215528
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
31366-23
Device description
"PLASTER SPREADER REDA 9"""
Published
2025-07-09
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
00810158215528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158215528008101582155288101582155280810158215528

GMDN Terms#

Term, Definition table
TermDefinition
Cast spreader, reusableA hand-operated instrument with specially designed blades intended to separate and spread hardened plaster, i.e., plaster that has already formed a cast around a patient's limb or body part. It is designed like large forceps with flat, outer-edge serrated blades that may be exchangeable and which are wedge-shaped (thin at the working end). The blades are intended to be prised between cut plaster so that when the device handles are squeezed the cast separates. It is typically made of high-grade stainless steel. 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

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Primary DI, Brand, Company table
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