FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660097011
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Morrison lens loop and probe
Catalog number
3745E
Device description
Morrison lens loop and probe, 5 1/2'', double-ended, curved, smooth loop, straight, ball tip probe, round handle
Published
2021-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660097011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660097011001906600970111906600970110190660097011

GMDN Terms#

Term, Definition table
TermDefinition
Enucleation scissorsA hand-held surgical instrument used to cut tissue during eye surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. 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
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21
00810163790454Diamatrix Ltd.DiamatrixHNQ2025-10-21
00190776412616MillenniumAvalign Technologies, Inc.HNQ2025-10-03
00190776412005MillenniumAvalign Technologies, Inc.HNQ2025-10-01
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00810163790331Diamatrix Ltd.DiamatrixHNQ2025-05-27
10649111487934Sklar InstrumentsSKLAR CORPORATIONHNQ2025-01-03
G2231196710Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-09-19
00810123480883Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480890Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480906Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480913Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
G2231196700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-01-12
14026704790675PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799579PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799661PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799678PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799685PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799692PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799708PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799715PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799722PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08