FDA.reportPublic FDA data

Devon

Primary DI
10884527015979
Brand
Devon
Company
Cardinal Health, Inc.
Model
31145785
Catalog number
31145785
Device description
Skin Marker,Regular Tip with Ruler
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
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
10884527015979PackageGS1100In Commercial Distribution
20884527015976PrimaryGS10
30884527015973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452701597910884527015979
2088452701597620884527015976
3088452701597330884527015973

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
25
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
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00754027700275RMAC SurgicalRMAC Surgical, IncFZZ2025-06-03
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
10884389289280Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01
10884389289310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01