FDA.reportPublic FDA data

N/A

Primary DI
57613327586560
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
HAR1120
Catalog number
HAR1120
Device description
Ultrasonic Scalpel Shears with Advanced Hemostasis
Published
2024-03-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLQSingle-use reprocessed ultrasonic surgical instruments

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233471000Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability Solutions2024-02-20NLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327586560PackageGS16In Commercial Distribution
07613327586565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332758656057613327586560
07613327586565076133275865657613327586565

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system holder/tip, reprocessedA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

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
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
07613327346237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2017-03-03