FDA.reportPublic FDA data

Medline

Primary DI
20888277416151
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ONBFCA11SR
Catalog number
ONBFCA11SR
Device description
ONBFCA11ST @VERSAPORT V2 OPT BLADELESS 1
Published
2023-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLMLaparoscope, general & plastic surgery, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLMLaparoscope, General & Plastic Surgery, ReprocessedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277416151PackageGS16In Commercial Distribution
10888277416154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827741615120888277416151
1088827741615410888277416154

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reprocessedA sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall. It is available in a variety of dimensions and/or designs. This is a previously used single-use device that has been processed for an additional single-use patient application.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10888277385511MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-07-18
20888277386164MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
20888277386768MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-03-01
20888277372457MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277384481MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277372594MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-31
20080196385000MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-01-14
20080196381828MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20080196384652MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20080196384775MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20080196385598MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20080196385628MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20193489000631MedlineMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277372464MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277376158MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277376165MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277378114MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277378404MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277378916MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277380315MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277381459MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277381466MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277381794MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277382388MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277382814MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277383279MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277383453MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277383460MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
40888277384928MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277385174MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09