FDA.reportPublic FDA data

Invenio

Primary DI
00840365900948
Brand
Invenio
Company
Gri-Alleset, Inc.
Model
525-037
Device description
Introducer Kit Micro 4fr X 45, cm W/ Nitinol Gw 21G Ndl Echo
Published
2025-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840365900945PackageGS110In Commercial Distribution
00840365900948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084036590094510840365900945
00840365900948008403659009488403659009480840365900948

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-china.com

Regulatory Flags#

DUNS number
015356845
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840365902317Invenio686-1362025-03-12
00840365908562InvenioVTI0022025-03-12
00840365900085Invenio682-264NL12025-03-12
00840365900092Invenio682-14732025-03-12
00840365900177InvenioMPR100211R12025-03-12
00840365900214Invenio682-1349R12025-03-12
00840365900238Invenio682-026NL12025-03-12
00840365900245Invenio40903WDS2025-03-12
00840365900290Invenio682-1660R12025-03-12
00840365900337Invenio682-16322025-03-12
00840365900344Invenio682-13992025-03-12
00840365900511Invenio40295POS2025-03-12
00840365900535Invenio40669SKS2025-03-12
00840365900542Invenio682-1493NL12025-03-12
00840365900627Invenio689-2282025-03-12
00840365900726Invenio40063LBS2025-03-12
00840365900764Invenio40026DSS2025-03-12
00840365900856Invenio525-0712025-03-12
00840365900924Invenio682-541R12025-03-12
00840365901464Invenio682-5842025-03-12

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Primary DI, Brand, Company table
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10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
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10813153028312CodanCodan US CorporationFPA2026-07-31
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00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23