FDA.reportPublic FDA data

PRINCETON

Primary DI
00850088713039
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
03500-38
Device description
FREEMAN MARKER 38MM Ø
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00850088713039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850088713039008500887130398500887130390850088713039

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking guide, reusableA device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012857277
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10080196320516MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-05
10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913916evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913985evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914395evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914418evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914425evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914814evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25