FDA.reportPublic FDA data

RMAC Surgical Marker

Primary DI
07540277009663
Brand
RMAC Surgical Marker
Company
RMAC Surgical, Inc
Model
SPL-21395
Device description
Sterile waterproof permanent utility marker with superfine tip
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
17540277009660PackageGS125In Commercial Distribution
17540277009677PackageGS1100In Commercial Distribution
07540277009663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754027700966017540277009660
1754027700967717540277009677
07540277009663075402770096637540277009663

GMDN Terms#

Term, Definition table
TermDefinition
Clerical marking penA non-dedicated pen designed for writing or making permanent and indelible markings or identifiers on physical records, consumables (e.g., specimen containers) or other equipment. It typically consists of a felt tip, on the end of an ink barrel, and a cap to prevent drying. It is not intended for making physical markings on a patient. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-888-299-2661sales@pharmatags.com

Regulatory Flags#

DUNS number
203768551
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540277000042PharmaTagsVCU04-M2026-10-15
00754027700237PharmaTagsPT-02PT-102026-07-20
07540277000035PharmaTagsIDN012026-06-26
07540277009687PharmaTagsSPL-1309222026-06-22
07540277009694PharmaTagsSPL-1309232026-06-22
07540277000011PharmaTagsTORRASC032026-06-09
07540277000615RMAC Surgical MarkerRM14512026-06-09
07540277010041RMAC SurgicalSPL-184012026-01-06
00754027700275RMAC SurgicalRM-1450XL2025-06-03
07540277000004PharmaTagsEASC01-DTR2026-02-06
07540277009656PharmaTagsSPL-1297902026-04-08
07540277009649PharmaTagsSPL-1292192026-03-12
17540277009646PharmaTagsSPL-1292192026-03-12
07540277009632PharmaTagsSPL-1200002026-03-03
17540277009639PharmaTagsSPL-1200002026-03-03
17540277000001PharmaTagsEASC01-DTR2026-02-06
00754027700107PharmaTagsSPL-98399PT-3M2026-02-02
00754027700114PharmaTagsSPL-103761PT-42026-02-02
00754027700145PharmaTagsSPL-81131PT-5-M2026-02-02
00754027700176PharmaTagsSPL-120337PT-72026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28