FDA.reportPublic FDA data

Jiyuan

Primary DI
16973672290059
Brand
Jiyuan
Company
Jiangsu Jiyuan Medical Technology Co .,Ltd.
Model
JY-PK-350-18-S
Device description
Flat type, 350mm, diameter 1.8mm, ARMI
Published
2022-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973672290059PackageGS110In Commercial Distribution
26973672290056PackageGS110In Commercial Distribution
06973672290052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697367229005916973672290059
2697367229005626973672290056
06973672290052069736722900526973672290052

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, single-useA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414764719
Device count
1
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
06973672291158ARMISH-02A2026-01-23
06973672291165ARMISH-03A2026-01-23
06973672291172ARMISH-02B2026-01-23
06973672291189ARMISH-03C2026-01-23
16973672291155ARMISH-02A2026-01-23
16973672291162ARMISH-03A2026-01-23
16973672291179ARMISH-02B2026-01-23
16973672291186ARMISH-03C2026-01-23
06973672291196ARMIJY-MIP-30002026-01-23
06973672291066JiyuanJY-CC-450-15-S2025-08-12
16973672291063JiyuanJY-CC-450-15-S2025-08-12
06973672291059JiyuanJY-CC-350-12-S2025-07-31
16973672291056JiyuanJY-CC-350-12-S2025-07-31
06973672290793JiyuanJY-CC-450-18-S2025-01-13
16973672290790JiyuanJY-CC-450-18-S2025-01-13
06973672290410WiScopeOTU-HJ012024-03-11
06973672290007JiyuanJY-DEH-0012022-02-17
06973672290014JiyuanJY-DEH-0022022-02-09
06973672290021JiyuanJY-DEH-0032022-02-09
06973672290038JiyuanJY-MIP-10002022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950190431006NAZhuji Pengtian Medical Instrument Co.,Ltd.HFB2026-03-31
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
06973672291066JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
16973672291063JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
00194613029302MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613033590MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613060480MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613106423MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613108076MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117641MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117726MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
06973672291059JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
16973672291056JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
00190776406974MillenniumAvalign Technologies, Inc.HFB2025-07-25
05010058082595InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058182592InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058080478InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
05010058180475InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
00190776401771MillenniumAvalign Technologies, Inc.HFB2025-06-13
00198506083013ELMED INCORPORATEDELMED INCORPORATEDHFB2025-05-22
05010058082588InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
05010058182585InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
00840183530112BR Surgical, LLCBR Surgical, LLCHFB2025-05-14
04049047044215GimmiGimmi GmbHHFB2025-05-14
04049047044246GimmiGimmi GmbHHFB2025-05-14
04049047044291GimmiGimmi GmbHHFB2025-05-14