FDA.reportPublic FDA data

Integra®

Primary DI
10381780102021
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
MCEN143
Catalog number
MCEN143
Device description
Wormald Anterior Skull Base and Pituitary Instrument Tray, 52.7cm L x 25cm W x 12cm D
Published
2018-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMOTRAY, SURGICAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780102021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010202110381780102021

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676747204Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747211Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747235Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747228Tray setSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993600128Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601927Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601934Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676741554Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741561Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741578Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741585Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741592Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741608Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741622Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741639Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741899Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250407778262FENTEXFENTEX medical GmbHMMO2025-02-19
00840217909396Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
00840217909402Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
40198459084776Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
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00848253002361InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002378InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002385InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002408InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253002606InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003092InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003115InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03
00848253003122InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03