FDA.reportPublic FDA data

NA

Primary DI
10888551019040
Brand
NA
Company
STERILMED, INC.
Model
ETHLCSC5
Catalog number
ETHLCSC5
Device description
HARMONIC SCALPEL COAGULATING SHEARS, LCS, PISTOL GRIP CURVED ACTIVE BLADE
Published
2016-09-22
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012571000REPROCESSED HARMONICSterilmed, Inc.2001-11-07NLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551019040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855101904010888551019040

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system holder/tip, reprocessedA sterile, hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, and is typically made of metal. This device is utilized in a variety of surgical disciplines. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15

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
10888277408708MedlineMEDLINE INDUSTRIES, INC.NLQ2020-11-02
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