FDA.report

Medline

Primary DI
20888277408705
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NLQScalpel, ultrasonic, reprocessed

Product Code Classifications

CodeDeviceSpecialtyClass
NLQSingle-Use Reprocessed Ultrasonic Surgical InstrumentsUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277408705PackageGS16In Commercial Distribution
10888277408708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827740870520888277408705
1088827740870810888277408708

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
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10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
37613327663366N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
37613327663380N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
37613327663410N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2025-08-27
20888277407760MEDLINEMEDLINE INDUSTRIES, INC.NLQ2025-02-14
20888277368498MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLQ2025-02-11
57613327586560N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
57613327586584N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
20193489081333MedlineMEDLINE INDUSTRIES, INC.NLQ2023-10-09
20888551045282NASTERILMED, INC.NLQ2020-01-10
10888551045230Ace + 7STERILMED, INC.NLQ2019-07-10
10888551045247Ace + 7STERILMED, INC.NLQ2019-07-10
10888551045278Ace + 7STERILMED, INC.NLQ2019-07-10
37613327348249N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-04-13
37613327346238N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-03-03
37613327346245N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-03-03
37613327346252N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-03-03
30885825014767N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825015788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825016013N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
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10888551010108NASTERILMED, INC.NLQ2016-09-22
10888551010115NASTERILMED, INC.NLQ2016-09-22
10888551010894NASTERILMED, INC.NLQ2016-09-22
10888551010900NASTERILMED, INC.NLQ2016-09-22