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
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15

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
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
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10817121000485Swift LoopCoroneo IncGAE2023-06-28
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16932503550052MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
16932503550069MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28