FDA.reportPublic FDA data

Medline

Primary DI
40193489463454
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
INV4C
Catalog number
INV4C
Device description
ACCUFIT 4 CHANNEL MRI COIL CVR,QSUM ONLY
Published
2021-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489463454PackageGS18In Commercial Distribution
10884389027929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348946345440193489463454
1088438902792910884389027929

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253069662CONVERTORSCardinal Health 200, LLCPUI2026-05-05
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10192253066586CONVERTORSCardinal Health 200, LLCPUI2025-11-07
10192253066531CONVERTORSCardinal Health 200, LLCPUI2025-09-24
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-08-06
10192253067842CONVERTORSCardinal Health 200, LLCPUI2025-06-30
10192253067859CONVERTORSCardinal Health 200, LLCPUI2025-06-30
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10192253066494CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066500CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066517CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066524CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066548CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066555CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066562CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066579CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066593CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066609CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066616CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066623CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066654CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066692CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066708CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066715CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066722CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066739CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066746CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066753CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253067941CONVERTORSCardinal Health 200, LLCPUI2025-06-05