FDA.reportPublic FDA data

MEDLINE RENEWAL

Primary DI
20888277368498
Brand
MEDLINE RENEWAL
Company
MEDLINE INDUSTRIES, INC.
Model
ACE14SR
Catalog number
ACE14SR
Device description
ACE14S @HARMONIC ACE, COAGULATION SHEARS
Published
2025-02-11
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277368498PackageGS16In Commercial Distribution
10888277368491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827736849820888277368498
1088827736849110888277368491

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
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
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
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
57613327586560N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
57613327586584N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2024-03-04
20193489081333MedlineMEDLINE INDUSTRIES, INC.NLQ2023-10-09
20888277408705MedlineMEDLINE INDUSTRIES, INC.NLQ2020-11-02
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
30885825016303N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825016310N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825016327N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825017331N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
30885825017348N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NLQ2016-09-23
10888551008020NASTERILMED, INC.NLQ2016-09-22
10888551010092NASTERILMED, INC.NLQ2016-09-22
10888551010108NASTERILMED, INC.NLQ2016-09-22
10888551010115NASTERILMED, INC.NLQ2016-09-22
10888551010894NASTERILMED, INC.NLQ2016-09-22
10888551010900NASTERILMED, INC.NLQ2016-09-22