FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660202415
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Quick coupling countersink
Catalog number
45-913
Device description
Quick coupling countersink, large, 4.5mm tip, T-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

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
00190660202415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660202415001906602024151906602024150190660202415

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

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Primary DI, Brand, Company table
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03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
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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