FDA.reportPublic FDA data

Medline

Primary DI
10193489085358
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ESSHROUD10
Catalog number
ESSHROUD10
Device description
SHROUD, ATTACHMENT, SMOKE EVAC, 10'
Published
2023-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489085355PackageGS120In Commercial Distribution
10193489085358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348908535520193489085355
1019348908535810193489085358

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, cool and dry place. Handle with care to avoid damage to the packaging and its content during transportation and storage.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242785BovieASPEN SURGICAL PRODUCTS, INC.FYD2026-09-18
10840113242792BovieASPEN SURGICAL PRODUCTS, INC.FYD2026-09-18
30845854655492PlumeSafe® X5™Conmed CorporationFYD2026-07-23
10705036046523MegadyneETHICON ENDO-SURGERY, LLCFYD2026-05-27
10860012888808Flamingo Funnel (miniSQUAIR) - LargeNASCENT SURGICAL, LLCFYD2026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
40845854081830VIROSAFEConmed CorporationFYD2021-01-20
10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
40845854053127MEGADYNE MICROSAFEConmed CorporationFYD2020-12-08
10845854053096MINIVACConmed CorporationFYD2020-11-20
10845854053102MINIVACConmed CorporationFYD2020-11-20
20845854082802VIROSAFEConmed CorporationFYD2020-11-02
20845854081775OR-VACConmed CorporationFYD2020-10-23
20845854081058OR-VACConmed CorporationFYD2020-10-21
30845854081024OR-VACConmed CorporationFYD2020-10-21
30845854081031OR-VACConmed CorporationFYD2020-10-21
30845854081048OR-VACConmed CorporationFYD2020-10-21
30845854081680NAConmed CorporationFYD2020-10-14
20845854081706BOWAConmed CorporationFYD2020-09-30
20845854053192PENADAPTConmed CorporationFYD2020-09-17
20845854061814BOWAConmed CorporationFYD2020-09-15
20845854061821BOWAConmed CorporationFYD2020-09-15
20845854060015VIROSAFEConmed CorporationFYD2020-09-13
20845854081805HarmonyAIRConmed CorporationFYD2020-09-11