FDA.reportPublic FDA data

Medline ReNewal

Primary DI
10888277356221
Brand
Medline ReNewal
Company
MEDLINE INDUSTRIES, INC.
Model
REP120828
Catalog number
REP120828
Device description
ETHICON ENDPH XCEL W/STABILITY SLEEVE,
Published
2016-10-14
Public version status
Update
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
10888277356221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827735622110888277356221

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reprocessedA sterile, rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter11Millimeter

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
true
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
true
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