FDA.reportPublic FDA data

Richard-Allan® Utility Marker with Labels

Primary DI
00840113222810
Brand
Richard-Allan® Utility Marker with Labels
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ML5847
Device description
Used to provide a permanent method of identifying objects in the operating room
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113222810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113222810008401132228108401132228100840113222810

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198459214035Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459218309Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459204401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459205842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459189777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-24
10198459166938Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459181269Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459159404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-20
10198459148750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-13
10198459141454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459141546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459133381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459134517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459122712Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122729Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459115929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119798Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459109164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-08
10198459074493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459075056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459078750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10195327655099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10195327668808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10198459024825Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29