FDA.report

MEDLINE RENEWAL

Primary DI
20888277386157
Brand
MEDLINE RENEWAL
Company
MEDLINE INDUSTRIES, INC.
Model
B12XTR
Catalog number
B12XTR
Device description
B12XT ENDPH XCEL BLADELESS TROCAR, W/ST
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

Related Records

Contact Domains

Product Codes

CodeName
NLMLaparoscope, general & plastic surgery, reprocessed

Product Code Classifications

CodeDeviceSpecialtyClass
NLMLaparoscope, General & Plastic Surgery, ReprocessedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277386157PackageGS16In Commercial Distribution
10888277386150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827738615720888277386157
1088827738615010888277386150

GMDN Terms

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

Contacts

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

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40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10888277385511MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-07-18
20888277386164MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
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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
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20888277376165MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
20888277378114MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
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20888277383453MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2023-10-09
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