FDA.reportPublic FDA data

Medline

Primary DI
10888277408708
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
HAR36MR
Catalog number
HAR36MR
Device description
HAR36M @HARMONIC ACE+ SHEARS W/O ADAPTIV
Published
2020-11-02
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
NLQScalpel, ultrasonic, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLQSingle-Use Reprocessed Ultrasonic Surgical InstrumentsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277408705PackageGS16In Commercial Distribution
10888277408708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827740870520888277408705
1088827740870810888277408708

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.

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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327663365N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
07613327663389N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
07613327663419N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
37613327663366N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
37613327663380N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
37613327663410N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
10888277407763MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-02-14
20888277407760MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-02-14
10888277368491MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLQ2025-02-11
20888277368498MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLQ2025-02-11
10193489081312MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-01-29
10193489081329MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-01-29
10888277674202MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-01-29
10888277681545MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-01-29
10888277681552MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-01-29
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
57613327586560N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
57613327586584N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
10193489081336MedlineMEDLINE INDUSTRIES, INC.NLQ2023-10-09
20193489081333MedlineMEDLINE INDUSTRIES, INC.NLQ2023-10-09
20888277408705MedlineMEDLINE INDUSTRIES, INC.NLQ2020-11-02
10888551045285NASTERILMED, INC.NLQ2020-01-10
20888551045282NASTERILMED, INC.NLQ2020-01-10
10888551045230Ace + 7STERILMED, INC.NLQ2019-07-10
10888551045247Ace + 7STERILMED, INC.NLQ2019-07-10
10888551045278Ace + 7STERILMED, INC.NLQ2019-07-10
07613327348248N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-04-13
37613327348249N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-04-13
07613327346237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-03-03