FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660202385
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Quick coupling countersink
Catalog number
45-910
Device description
Quick coupling countersink, 2 1/4'', mini, 1.0mm tip, round 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWWCOUNTERSINK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660202385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660202385001906602023851906602023850190660202385

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07
04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277390072MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
00810074306232Small Cannulated Countersink AO 125mmOsteocentric Technologies, Inc.HWW2024-12-06
00810111223416Depth gauge countersinkTreace Medical Concepts, Inc.HWW2024-11-19
04048266076830N/AMerete GmbHHWW2024-10-18
07612334236654NASynthes GmbHHWW2024-10-09
08800089451128Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHWW2024-09-25
00889795137098Phantom® Fibula Nail SystemPARAGON 28, INC.HWW2024-09-24
B504OM45300070StrykerProvisionHWW2024-08-26
B504OMAR8943050ArthrexProvisionHWW2024-08-13
B504OM127000040Extremity MedicalProvisionHWW2024-08-12
008100283950772.0/2.4 CountersinkTrilliant Surgical, LLCHWW2024-06-07
008100283950843.0/4.0 CountersinkTrilliant Surgical, LLCHWW2024-06-07
B504OM3108900SynthesProvisionHWW2024-05-17
B504OMP06N07110In2BonesProvisionHWW2024-05-17
B504OMP2091030000Paragon 28ProvisionHWW2024-05-17
B504OMA39370MedartisProvisionHWW2024-05-13
B504OMA39380MedartisProvisionHWW2024-05-13
B504OM3109710SynthesProvisionHWW2024-05-06
05055662969818COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHWW2024-04-01
B504OMHSINK350TriMedProvisionHWW2024-03-28
08800089445516Surgical InstrumentJeil Medical CorporationHWW2024-03-19