FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660034559
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Presbyterian hospital staphylorrhaphy elevator
Catalog number
20-926
Device description
Presbyterian hospital staphylorrhaphy elevator, 7'', double-ended, curved, semi-sharp blades, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660034559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660034559001906600345591906600345590190660034559

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800102Adler Instrument CompanyAdler, Inc.GEG2026-05-26
00190776417987MillenniumAvalign Technologies, Inc.GEG2026-03-23
00190776417536MillenniumAvalign Technologies, Inc.GEG2026-02-27
B382SD9141051070Surgical DirectSurgical Direct, Inc.GEG2026-02-17
00190776416577MillenniumAvalign Technologies, Inc.GEG2026-02-16
B382SD62432250Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD9141051050Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD23020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD23030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD671050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD6716050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051060Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051080Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9206611040Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921316170Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921381050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD92263910000Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9226411030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD922658020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD923862510Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD940111100Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD1467010200Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD481003700Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD48820100Surgical DirectSurgical Direct, Inc.GEG2026-02-06
G3831056WM853543SURJEXSURJEXGEG2026-01-31
00190776415501MillenniumAvalign Technologies, Inc.GEG2026-01-27
00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
00841336106819Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02