FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660001650
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Austin strut caliper and measuring gauge
Catalog number
14-100
Device description
Austin strut caliper and measuring gauge, 6 1/4'', straight shaft, prongs at 3.5mm and 4.5mm, groove at 4.0mm, 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
JYJGAUGE, MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660001650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660001650001906600016501906600016500190660001650

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

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Primary DI, Brand, Company table
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04054462907588evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907595evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907601evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462908097evonosevonos GmbH & Co. KGJYJ2026-08-18
09348811109439INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-05-29
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
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00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
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