FDA.reportPublic FDA data

GEM-CLIP

Primary DI
03661624005849
Brand
GEM-CLIP
Company
VITALITEC SURGICAL
Model
GEM2431
Catalog number
GEM2431
Device description
Titanium Hemostatic Clip - MicroClips
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPClip, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661624005856PackageGS130Not in Commercial Distribution
03661624006563PackageGS148Not in Commercial Distribution
13661522039455PackageGS130In Commercial Distribution
03661624005849PreviousGS10
03661522039458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661624005856036616240058563661624005856
03661624006563036616240065633661624006563
1366152203945513661522039455
03661624005849036616240058493661624005849
03661522039458036615220394583661522039458

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height2.6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 508-747-6033e.knupp@peters-surgical.com
508-7476033eknuppesi@aol.com

Regulatory Flags#

DUNS number
262783206
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661624004651CLIP 9W9060W90602015-09-17
03661624004675CLIP 9J9180J91802015-09-17
03661624000172SLS-CLIPB2120-1B2120-12015-09-17
03661624000158SLS-CLIPB2180-1B2180-12015-09-17
03661624004774CLIP 9B9180B91802015-09-17
03661624005863GEM-CLIPGEM1521GEM15212015-09-17
03661624000059SLS-CLIPJ1120-1J1120-12015-09-17
03661624000110SLS-CLIPL5180-1L5180-12015-09-17
03661624004750CLIP 9L9180L91802015-09-17
03661624000219SLS-CLIPO4120-1O4120-12015-09-17
03661624004835CLIP 9O9120O91202015-09-17
03661624000097SLS-CLIPR1120-1R1120-12015-09-17
03661624000073SLS-CLIPR1180-1R1180-12015-09-17
03661624004712CLIP 9R9180R91802015-09-17
03661624000196SLS-CLIPV3120-12015-09-17
03661624004811CLIP 9V9120V91202015-09-17
03661624000011SLS-CLIPW6060-1W6060-12015-09-17
03661624006334SLS-CLIPW6060-1W6060-12015-09-17
03661624000035SLS-CLIPJ1180-1J1180-12015-09-17
03661624006358SLS-CLIPJ1120-1J1120-12015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225510MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
14026704725301WECKTELEFLEX INCORPORATEDFZP2025-07-03
14026704613868WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613875WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613844WECKTELEFLEX INCORPORATEDFZP2025-04-28
14026704613851WECKTELEFLEX INCORPORATEDFZP2025-04-24
14026704725264WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725271WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725288WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725295WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725318WECKTELEFLEX INCORPORATEDFZP2024-03-13
10193489144765MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144789MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144796MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144819MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20