FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660034665
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Sayre periosteal elevator
Catalog number
20-942
Device description
Sayre periosteal elevator, 6 1/2'', double-ended, curved, sharp blades, flat 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
KADELEVATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660034665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660034665001906600346651906600346650190660034665

GMDN Terms#

Term, Definition table
TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, 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
00757770683567Bausch + LombBausch & Lomb IncorporatedKAD2026-05-11
09348811101655INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783053Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783060Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783077Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783084Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783091Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783107Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783114Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783121Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783138Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783145Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783152Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
09348811101501INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
09348811101532INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
00757770636341Bausch + LombBausch & Lomb IncorporatedKAD2025-11-15
04250381888438Hurd elevator/retractorSpiggle & Theis Medizintechnik GmbHKAD2025-10-06
04250676733900Sewall antrum elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-10-05
04250381860588Weber elevator, double endedSpiggle & Theis Medizintechnik GmbHKAD2025-09-25
04250381852057Williger elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24
04250676714497Langenbeck-Quervain elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24