FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158219359
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
33450-01
Device description
"LEAD HAND ADULT SIZE 12.75"""
Published
2026-03-12
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
00810158219359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158219359008101582193598101582193590810158219359

GMDN Terms#

Term, Definition table
TermDefinition
Wrist splint, reusableA rigid external support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. 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
00810158215955PRINCETON45190-012026-08-25
00810158217409PRINCETON41161-042026-08-25
00850088713565PRINCETON34536-032026-08-25
00850088713572PRINCETON34815-062026-08-25
00850088713589PRINCETON33475-012026-08-25
00850088713596PRINCETON11174-122026-08-25
00850088713602PRINCETON75450-132026-08-25
00850088713619PRINCETON11102-202026-08-25
00850088713626PRINCETON51131-222026-08-25
00850088713220PRINCETON93216-162026-08-14
00850088713237PRINCETON93190-162026-08-14
00850088713244PRINCETON47474-022026-08-14
00850088713251PRINCETON17170-302026-08-14
00850088713299PRINCETON34547-232026-08-14
00850088713305PRINCETON19310-052026-08-14
00850088713312PRINCETON19694-012026-08-14
00850088713329PRINCETON19694-022026-08-14
00850088713336PRINCETON19694-032026-08-14
00850088713343PRINCETON19802-162026-08-14
00850088713350PRINCETON09283-152026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688919MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688926MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688933MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688940MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688957MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688964MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277689121MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10080196321384MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277688995MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689008MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689015MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689022MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689039MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689046MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689053MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689060MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689077MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689084MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689091MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689107MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689114MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10080196320417MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09