FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660122027
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ambler osteotome
Catalog number
59-172
Device description
Ambler osteotome, 5 1/2'', straight, 12.0mm wide, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660122027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660122027001906601220271906601220270190660122027

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776432805MillenniumAvalign Technologies, Inc.GFI2026-09-29
00190776432102MillenniumAvalign Technologies, Inc.GFI2026-09-22
04054462912070evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912094evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912216evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912223evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912254evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912261evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912421evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912520evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912940evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912957evonosevonos GmbH & Co. KGGFI2026-08-19
04054462900305evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900312evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900329evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900336evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900343evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900350evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900367evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912087evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912100evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912131evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912148evonosevonos GmbH & Co. KGGFI2026-08-18
00841435123717TecometTECOMET INC.GFI2026-07-30
00841435123724TecometTECOMET INC.GFI2026-07-30
00841435123731TecometTECOMET INC.GFI2026-07-30
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
00841435123557TecometTECOMET INC.GFI2025-02-07
00841435123564TecometTECOMET INC.GFI2025-02-07