FDA.reportPublic FDA data

Anrei

Primary DI
16926839810843
Brand
Anrei
Company
Anrei Medical(HZ) Co.,Ltd.
Model
699 001 000
Device description
Ambu® Cysto Grasper
Published
2025-07-03
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

Product Codes#

Code, Name table
CodeName
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16926839810843PackageGS110In Commercial Distribution
26926839810840PackageGS110In Commercial Distribution
06926839810846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692683981084316926839810843
2692683981084026926839810840
06926839810846069268398108466926839810846

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529128653
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
false
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
26926839812349NAM00591010M005910102025-10-27
26926839812370NAM00591200M005912002025-10-27
26926839812400NAM00591210M005912102025-10-27
26926839812431NAM00591220M005912202025-10-27
26926839812462NAM00591230M005912302025-10-27
26926839812493NAM00591240M005912402025-10-27
26926839812523NAM00591250M005912502025-10-27
06948318963126AnreiRNAS-3024-GY-1952025-01-07
16948318996794VersaGrasp Single use Grasping ForcepsM0067802000M00678020002023-11-16
06948318996094VersaGrasp Single use Grasping ForcepsM0067802000M00678020002023-11-01
26948318968828AnreiM005151012021-05-14
06948318912292AnreiHG-III-2C2020-11-01
06948318912308AnreiHG-VII-2C2020-11-01
26948318968606RescueM005383512019-02-28
26948318968613RescueM005274512019-02-28
26948318968620RescueM005275512019-02-28
26948318968637RescueM005276512019-02-28
26948318968644RescueM005277512019-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603215401Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215418Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215579Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215586Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603222492Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603222508Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237281Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237298Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237304Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237311Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029957ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029964ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029971ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029988ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029995ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030007ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030014ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030021ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18