FDA.reportPublic FDA data

NA

Primary DI
03596010025043
Brand
NA
Company
Smith & Nephew, Inc.
Model
013593
Catalog number
013593
Device description
SUTURE RETRIEVER
Published
2015-08-30
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881224000ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLEAcufex Microsurgical, Inc.1988-06-01GAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010025047PackageGS16In Commercial Distribution
03596010025043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601002504723596010025047
03596010025043035960100250433596010025043

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556828090XT Revision Ankle Replacement SystemMJV551TMJV551T2022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10888277385931MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAE2025-02-14
06948318938032AnreiAnrei Medical(HZ) Co.,Ltd.GAE2025-01-07
10080196074082MedlineMEDLINE INDUSTRIES, INC.GAE2023-10-13
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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
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10817121000485Swift LoopCoroneo IncGAE2023-06-28
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16932503550052MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
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