FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660033231
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Cushing ''Little Joker'' periosteal elevator
Catalog number
20-180
Device description
Cushing ''Little Joker'' periosteal elevator, 6'', curved, 6.0mm wide blade, solid 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
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660033231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660033231001906600332311906600332310190660033231

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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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04058749082357NAFehling Instruments GmbH & Co. KGHAO2026-03-05
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00810123209835Adler Instrument CompanyAdler, Inc.HAO2026-02-10
04058749068443NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
00873263009345Visualase Anchor Bolt DriverFHC, INC.HAO2025-12-12
00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009369Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009376Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009390Visualase Sterilization & Storage TrayFHC, INC.HAO2025-12-12
00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
04058749001846NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749002010NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749068467NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069969NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069976NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08