FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344203444
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYKEHEMO15
Catalog number
DYKEHEMO15
Device description
HEMOCLIP 15MM
Published
2026-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344203441PackageGS110In Commercial Distribution
30197344203448PackageGS15In Commercial Distribution
10197344203444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734420344120197344203441
3019734420344830197344203448
1019734420344410197344203444

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344203437MEDLINEMEDLINE 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
46932503530536SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30