FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660086886
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Skin hook
Catalog number
37-724
Device description
Skin hook, 7'', 5 sharp prongs, 7.0mm diameter, square 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
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
00190660086886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660086886001906600868861906600868860190660086886

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
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
00190776407346MillenniumAvalign Technologies, Inc.GDG2026-07-28
B382SD907072080Surgical DirectSurgical Direct, Inc.GDG2026-07-27