FDA.report

Ambler Surgical

Primary DI
00190660201845
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Plate bending iron
Catalog number
45-690
Device description
Plate bending iron, 4 3/4'', for mini for finger 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
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications

CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660201845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660201845001906602018451906602018450190660201845

GMDN Terms

TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. 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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