FDA.report

Ambler Surgical

Primary DI
00190660201883
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Plate bending pliers
Catalog number
45-697
Device description
Plate bending pliers, 8 3/4'', for 2.7mm and 3.5mm plates
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
HTCPLIERS, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660201883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660201883001906602018831906602018830190660201883

GMDN Terms

TermDefinition
Surgical flat-nosed pliersA heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. 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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00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
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00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
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00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

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