FDA.reportPublic FDA data

Swift Loop

Primary DI
00817121000464
Brand
Swift Loop
Company
Coroneo Inc
Model
1010643
Catalog number
1010643
Device description
Silicone Elastomer Loops with Blunt Needle
Published
2023-06-28
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
GAESnare, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817121000461PrimaryGS10
00817121000464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712100046110817121000461
00817121000464008171210004648171210004640817121000464

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vessel loopA nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5143369230info@coroneo.com

Regulatory Flags#

DUNS number
255276362
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10817121000171Aortic Prosthesis Indexing Cone101060510106052022-09-28
00817121000532Spreader arm - Neonate sternum retractor101083510108352024-02-01
00817121000549Spreader arm - Neonate sternum retractor101083710108372024-02-01
00817121000556Spreader arm - Infant sternum retractor101084210108422024-02-01
00817121000563Spreader arm - Infant sternum retractor101084410108442024-02-01
00817121000570Pinion for pediatric retractors101085010108502024-02-01
10817121000584Pediatric sternum retractor, infant110021011002102024-02-01
10817121000591Pediatric sternum retractor, neonate110021111002112024-02-01
10817121000492COR-VALV, Artial tissue retractor system110004111000412023-07-06
10817121000508COR-VALV Atrial tissue retractor system110004211000422023-07-06
10817121000515COR-VASC System with articulated arm (Large)110022911002292023-07-06
10817121000522COR-VASC System with articulated arm (Small)110023011002302023-07-06
10817121000201COR-VALV Aortic retractor cables with fitting101118110111812023-06-30
10817121000393COR-VALV Intercostal retractor cable101173910117392023-06-30
00817121000204COR-VALV Aortic retractor cables with fitting101118110111812023-06-30
00817121000396COR-VALV Intercostal retractor cable101173910117392023-06-30
00817121000433COR-VASC Articulated arm clamping system110034911003492023-06-28
10817121000317Pinion - Large101171310117132022-09-29
10817121000461Swift Loop101064310106432023-06-28
10817121000478Swift Loop101081510108152023-06-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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16932503550052MTMicro-Tech (Nanjing) Co., Ltd.GAE2023-06-28
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