FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277681552
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SCD48RH
Catalog number
SCD48RH
Device description
SCD48 @SONICISION CORDLESS ULTRASONIC D
Published
2025-01-29
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
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
K170955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170955000Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren2017-07-03NLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277681552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827768155210888277681552

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic blunt dissectorA sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.

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