FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660001957
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
House strut caliper
Catalog number
14-146
Device description
House strut caliper, 6 1/2'', malleable, straight shaft, straight, marker 5.0mm from tip, hexagonal 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
JYZROD, MEASURING EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYZRod, Measuring EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660001957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660001957001906600019571906600019570190660001957

GMDN Terms#

Term, Definition table
TermDefinition
Fistula probeA slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. 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
04250676726889Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2025-09-24
04250676726865Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2024-11-11
00887482047644Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113790Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113806Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113813Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00842331191091Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
G586E7214780Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
00190776044275AvalignAvalign Technologies, Inc.JYZ2023-11-13
00190776044299AvalignAvalign Technologies, Inc.JYZ2023-09-28
00190776319571MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
00190776319588MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
G043655090BEARBear-Ent, LLCJYZ2023-08-08
G043655100BEARBear-Ent, LLCJYZ2023-08-08
00190776369729MillenniumAvalign Technologies, Inc.JYZ2023-02-22
14026704805188PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805195PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805201PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805193PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805186PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805209PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805218PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
00842331174711Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00842331179525Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00840343700584Gen2SURGIX MEDICAL LLCJYZ2022-10-18
G277G2E9009610Gen2SURGIX MEDICAL LLCJYZ2022-09-23
04250676726872Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2022-09-12
00190776044282AvalignAvalign Technologies, Inc.JYZ2021-11-03
00190776044305AvalignAvalign Technologies, Inc.JYZ2021-11-03
B351B655100BEARMytamed, Inc.JYZ2021-11-01