FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660085858
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Millard hook
Catalog number
37-800
Device description
Millard hook, 3 1/4'', 2 sharp prongs, 18.0mm spread, flat handle
Published
2021-01-07
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660085858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660085858001906600858581906600858580190660085858

GMDN Terms#

Term, Definition table
TermDefinition
Nerve/vessel retractorA hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. 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
G141520422030Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
G141520422040Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
00724995267896Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-25
00190776432379MillenniumAvalign Technologies, Inc.GDG2026-09-24
00190776432423MillenniumAvalign Technologies, Inc.GDG2026-09-24
00724995267483Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267490Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267506Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267513Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267520Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267544Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267551Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267568Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267575Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267582Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267599Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267605Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267612Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267629Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00850088713954PRINCETONPrinceton Medical Group, Inc.GDG2026-09-22
00190776431099MillenniumAvalign Technologies, Inc.GDG2026-09-21
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25
00190776419660MillenniumAvalign Technologies, Inc.GDG2026-08-23
00190776417161MillenniumAvalign Technologies, Inc.GDG2026-08-19
00190776417079MillenniumAvalign Technologies, Inc.GDG2026-08-18
00190776422219MillenniumAvalign Technologies, Inc.GDG2026-07-31