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

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
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29
03596010040077NA1118021118022015-08-25
00885556582213RALLY71271560712715602015-10-08
00885556582220RALLY71271570712715702015-10-08

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
10888277385931MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAE2025-02-14
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
06932503550055LesionHunter(TM) Rotatable Nitinol Cold SnareMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
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