FDA.reportPublic FDA data

EndosacTM

Primary DI
10862242000364
Brand
EndosacTM
Company
APEX MEDICAL TECHNOLOGIES, INC.
Model
ES-1
Catalog number
ES-1
Device description
Specimen Collection Container
Published
2024-09-05
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
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930313000APEX SPECIMEN BAGApex Medical Technologies, Inc.1993-03-18LIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10862242000364PackageGS18In Commercial Distribution
00862242000367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086224200036410862242000364
00862242000367008622420003678622420003670862242000367

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-535-0216sales@zenithmedical.com

Regulatory Flags#

DUNS number
154115885
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
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
00862242000305Hy-GeneTM Seminal Fluid Collection KitACK-121ACK-1212024-09-05
00862242000367EndosacTMES-1ES-12024-09-05
00862242000312Hy-GeneTM Seminal Fluid Collection KitACK-121ACK-1212024-09-05
00862242000336Male-FactorPakTMMFP-130MFP-1302024-09-05

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Primary DI, Brand, Company table
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05060441760043binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760033binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760040binx ioBINX HEALTH LIMITEDLIO2025-09-03
00848838066665Amies Clear Gel,Single Swab PK/500REMEL, INC.LIO2025-06-18
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00848838066689Amies Clear Gel,Dual Swab PK/500REMEL, INC.LIO2025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50REMEL, INC.LIO2025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100REMEL, INC.LIO2025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50REMEL, INC.LIO2025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
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