FDA.reportPublic FDA data

RMAC Surgical

Primary DI
07540277010041
Brand
RMAC Surgical
Company
RMAC Surgical, Inc
Model
SPL-18401
Device description
Sterile permanent waterproof utility marker with superfine tip
Published
2026-01-06
Public version status
Update
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
HRPPen, Marking, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRPPen, Marking, SurgicalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754027701002PackageGS1100Not in Commercial Distribution
17540277010048PackageGS1100In Commercial Distribution
17540277999978PackageGS11000In Commercial Distribution
07540277010041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1075402770100210754027701002
1754027701004817540277010048
1754027799997817540277999978
07540277010041075402770100417540277010041

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
00841668142974DISPOSABLE REGULAR MARKING PENS 10/BOXKATENA PRODUCTS, INC.HRP2022-12-13
00841668142981DISPOSABLE MICRO MARKING PENS 10/BOXKATENA PRODUCTS, INC.HRP2022-12-13
00841668114360Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668114377Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668114384Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668113219Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125427Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125434Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
00841668125441Marking PenKATENA PRODUCTS, INC.HRP2020-09-14
10809160002803Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002810Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002827Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160002834Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003121Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003138Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003145Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003152Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003237Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003244Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160003251Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
10809160004449Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
30809160003132Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160019556Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160019563Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022075Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022082Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022099Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022105Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20
20809160022112Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.HRP2016-08-20