FDA.reportPublic FDA data

Cyst Puncture Needle without Stylet

Primary DI
07350025912318
Brand
Cyst Puncture Needle without Stylet
Company
Vitrolife Sweden AB
Model
14804
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNAInstrument, Manual, Specialized Obstetric-Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862365000NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURESwemed Laboratories, Inc.1986-07-07HIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025912315PackageGS15Not in Commercial Distribution
07350025912318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591231517350025912315
07350025912318073500259123187350025912318

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic cyst-aspiration setA collection of sterile devices designed to stabilize and aspirate a cyst or other internal anatomical structure under direct endoscopic vision during a surgical procedure, typically enabling aspiration of fluid without leakage into the surrounding anatomy (e.g., the peritoneal cavity). It typically consists of a long, slender, sharply-pointed, metal needle (e.g., stainless steel) within an aspiration tube [e.g., stainless steel or polycarbonate (PC)] that is applied to the lesion with suction; it may include adaptors and tubing to connect to the source of suction. This is a single-use device.

Regulatory Flags#

DUNS number
631805488
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07350025910307OVOIL100292016-09-13
07350025910901EmbryoGlue101902022-01-28
17350025911660Ultrasound Transmission Gel142032016-09-13
07350025911618Ultrasound Transducer Cover142212025-04-16
07350025911625Ultrasound Transducer Cover142202025-04-16
07350025911632Ultrasound Transducer Cover142192025-04-16
17350025911615Ultrasound Transducer Cover142212025-04-16
17350025911622Ultrasound Transducer Cover142202025-04-16
17350025911639Ultrasound Transducer Cover142192025-04-16
07350025914220RapidWarm Blast101202016-09-13
17350025910762HYASE-10X101762021-12-31
07350025910604Gx-IVF101712021-05-21
07350025910611Gx-TL101722021-05-21
07350025910628Gx-MOPS PLUS101732021-05-21
07350025910314OVOIL HEAVY101742020-08-25
07350025914800RapidVit Oocyte101212019-12-14
07350025914817RapidWarm Oocyte101222019-12-14
17350025910274ICSI101112016-09-13
17350025914784SpermGrad101382016-09-13
17350025914791SpermGrad101392016-09-13

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00841019123393KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
00841019123409KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-07-19
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04719894433424Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2025-03-10
00841019122822KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2025-02-15
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00841019122341KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2024-09-14
04719894432540Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
04719894432557Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.KNA2024-04-08
00841019121801KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2023-11-03
GYNX102001GynexGYNEX CORPORATIONKNA2023-06-28
00841019121023KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-06-03
00841019120996KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
00841019121009KirwanKIRWAN SURGICAL PRODUCTS LLCKNA2022-05-17
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00653160331103CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-11-04
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10653160326045CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
00653160326048CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKNA2019-04-13
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