FDA.reportPublic FDA data

Single Use Hemoclip

Primary DI
06970401811229
Brand
Single Use Hemoclip
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-G-HR-195-12-135-Y
Published
2018-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212669000Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd.2022-05-27PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401813282PackageGS110In Commercial Distribution
26970401813296PackageGS15In Commercial Distribution
06970401811229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181328216970401813282
2697040181329626970401813296
06970401811229069704018112296970401811229

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

Regulatory Flags#

DUNS number
544434963
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970401812110Single Use Grasping ForcepsMD-C-GF18062023-02-07
06970401813490Single Use GuidewireMD-S-GW35452019-03-23
06970401813766Single Use GuidewireMD-A-GW35452021-09-27
06970401815661Single Use GuidewireMD-S-GW25452020-06-17
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27
06936534325569Single Use Urinary GuidewireMD-A1-UW28152023-11-27
06936534325576Single Use Urinary GuidewireMD-A1-UW28182023-11-27
06936534325583Single Use Urinary GuidewireMD-A1-UW28202023-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344203437MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
10197344203444MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
00860014822704EndoFix Tissue Fixation DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
00860014822711Secure Suture Locking DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
46932503530819Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530833Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530840Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530864Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530871Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530895Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530918Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530932Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530956Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530970Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530994Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535012Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535029Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535036Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535043Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535050Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530666RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530727RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530390SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530413SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530420SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530444SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530451SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530468SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530512SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530529SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30