FDA.reportPublic FDA data

MEDLINE RENEWAL

Primary DI
10888277385931
Brand
MEDLINE RENEWAL
Company
MEDLINE INDUSTRIES, INC.
Model
AR4068CRH
Catalog number
AR4068CRH
Device description
AR-4068C SUTURELASSO SD,CRESCENT
Published
2025-02-14
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
GAESNARE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAESnare, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277385931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827738593110888277385931

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reprocessedA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320417MEDLINEMDS30102MDS301022026-09-09
10080196320424MEDLINEMDS30103MDS301032026-09-09
10080196320431MEDLINEMDS30104MDS301042026-09-09
10080196320509MEDLINEMDS30202MDS302022026-09-09
10080196320523MEDLINEMDS30204MDS302042026-09-09
10080196320530MEDLINEMDS30205MDS302052026-09-09
10080196320660MEDLINEMDS30301MDS303012026-09-09
10080196320721MEDLINEMDS30302MDS303022026-09-09
10080196320752MEDLINEMDS30303MDS303032026-09-09
10080196320790MEDLINEMDS30304MDS303042026-09-09
10080196320806MEDLINEMDS30305MDS303052026-09-09
10080196321179MEDLINEMDS30405MDS304052026-09-09
10080196321384MEDLINEMDS30603MDS306032026-09-14
10197344220083MEDLINEDYNJP2530TWLDYNJP2530TWL2026-09-18
10197344220090MEDLINEDYNJP2540TWLDYNJP2540TWL2026-09-18
10888277198739MEDLINEMDT821231QMDT821231Q2026-09-18
10888277688896MEDLINEMDS30106BMDS30106B2026-09-18
10888277688902MEDLINEMDS30107BMDS30107B2026-09-18
10888277688919MEDLINEMDS30108BMDS30108B2026-09-18
10888277688926MEDLINEMDS30109BMDS30109B2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16926839812366NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
16926839812397NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
16926839812427NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
16926839812458NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
16926839812489NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
16926839812519NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812370NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812400NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812431NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812462NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812493NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
26926839812523NAAnrei Medical(HZ) Co.,Ltd.GAE2025-10-27
10193489038002MEDLINEMEDLINE INDUSTRIES, INC.GAE2025-02-22
20193489038009MEDLINEMEDLINE INDUSTRIES, INC.GAE2025-02-22
06948318938032AnreiAnrei Medical(HZ) Co.,Ltd.GAE2025-01-07
10080196074082MedlineMEDLINE INDUSTRIES, INC.GAE2023-10-13
10884389027004MedlineMEDLINE INDUSTRIES, INC.GAE2023-10-13
30080196074086MedlineMEDLINE INDUSTRIES, INC.GAE2023-10-13
40884389027005MedlineMEDLINE INDUSTRIES, INC.GAE2023-10-13
10888277381407MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAE2023-10-09
20888277381404MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAE2023-10-09
10817121000461Swift LoopCoroneo IncGAE2023-06-28
10817121000478Swift LoopCoroneo IncGAE2023-06-28
10817121000485Swift LoopCoroneo IncGAE2023-06-28
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06932503550062LesionHunter(TM) Rotatable Nitinol Cold SnareMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
06932503550079LesionHunter(TM) Rotatable Nitinol Cold SnareMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
16932503550052MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
16932503550069MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
16932503550076MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28