FDA.reportPublic FDA data

Medline

Primary DI
10888277384682
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ASC550001RH
Catalog number
ASC550001RH
Device description
ASC 5500-01 MENIVAC ARTHROW W/SUCTION,
Published
2022-04-08
Public version status
New
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
NUJElectrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171324000Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.2017-06-23NUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277384682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827738468210888277384682

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessedA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
00850044399000NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
10888277408739MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
10888277325227MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277391987MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277414907MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680326MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680333MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680340MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680357MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680371MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680395MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680432MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719330MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719354MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719378MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01