FDA.report

Ambler Surgical

Primary DI
00190660218331
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ochsner gallbladder trocar
Catalog number
195-328
Device description
Ochsner gallbladder trocar, 6'', 28 French, for 24 French catheter
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660218331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660218331001906602183311906602183310190660218331

GMDN Terms

TermDefinition
Suprapubic catheter introducerA rigid surgical instrument(s) intended to gain percutaneous suprapubic access via the lower abdominal wall, to the urinary bladder for placement of a drainage catheter. It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel or durable plastic. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
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00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

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