FDA.report

Ambler Surgical

Primary DI
00190660108366
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Bone impactor
Catalog number
45-461
Device description
Bone impactor, 6 1/4'', 11.0mm x 18.0mm tip, square handle
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
HWAIMPACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660108366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660108366001906601083661906601083660190660108366

GMDN Terms

TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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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