FDA.reportPublic FDA data

RMAC Surgical

Primary DI
00754027700275
Brand
RMAC Surgical
Company
RMAC Surgical, Inc
Model
RM-1450XL
Device description
Mini prep-resistant skin marker
Published
2025-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754027700272PackageGS1400In Commercial Distribution
10754027700289PackageGS11000In Commercial Distribution
00754027700275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075402770027210754027700272
1075402770028910754027700289
00754027700275007540277002757540277002750754027700275

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking guide, single-useA 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 single-use 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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540277010041RMAC SurgicalSPL-184012026-01-06
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
00754027700268PharmaTagsSPL-18461PT-102026-02-02
00754027700718PharmaTagsSPL-48734PT-102026-02-02
00754027700725PharmaTagsSPL-60343PT-52026-02-02
00754027700732PharmaTagsSPL-60956PT-52026-02-02
00754027700749PharmaTagsSPL-61164PT-402026-02-02
00754027700756PharmaTagsSPL-81133PT-5-M2026-02-02
00754027700770PharmaTagsSPL-95471PT-52026-02-02
00754027700787PharmaTagsSPL-956562026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115237Opti-TattQfixFZZ2026-05-29
00841439115244Opti-TattQfixFZZ2026-05-29
00841439115251Opti-TattQfixFZZ2026-05-29
16931918101040AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918108414AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918152356AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918161327AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918172934AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
10080196771844MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312710MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
40080196312741MEDLINEMEDLINE INDUSTRIES, INC.FZZ2026-01-12
10198956206045CARDINAL HEALTHCardinal Health 200, LLCFZZ2025-11-07
00661392004511LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
00661392004528LSL HEALTHCARELSL Industries, LLCFZZ2025-10-30
10080196771851MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389025949MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389711798MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
10884389362402MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-10
10080196326006MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-02
10198459271694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2025-02-23
00714646001290IsoMark™Bionix, LLCFZZ2025-02-20
10884389610312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-08-04
10080196031436Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2024-07-29
10197106628232CARDINAL HEALTHCardinal Health 200, LLCFZZ2024-05-07
10860010334574InkWell Health Inkwell Health LtdFZZ2023-12-14
10884389106358MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
20193489027218MedlineMEDLINE INDUSTRIES, INC.FZZ2023-12-11
10884389025925MedlineMEDLINE INDUSTRIES, INC.FZZ2023-10-13
00630094177267Bioseal Inc.BIOSEALFZZ2023-10-03
00630094177274Bioseal Inc.BIOSEALFZZ2023-10-03