FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660050597
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Desmarres chalazion forceps
Catalog number
2211E
Device description
Desmarres chalazion forceps, 20.0mm solid lower plate, 12.0mm x 14.0mm open upper plate, cross-action 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
HODClamp, eyelid, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HODClamp, Eyelid, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660050597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660050597001906600505971906600505970190660050597

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

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

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Primary DI, Brand, Company table
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00757770524426Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HOD2026-02-23
G2231139450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-11-05
G2231140730Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-09-05
00757770494071Bausch + LombBausch & Lomb IncorporatedHOD2025-08-15
G2231115290Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-08-11
00757770485574Bausch + LombBausch & Lomb IncorporatedHOD2025-08-08
G22312045700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
G223M12045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
00757770481811Bausch + LombBausch & Lomb IncorporatedHOD2024-12-30
00757770472277Bausch + LombBausch & Lomb IncorporatedHOD2024-11-21
G223147970530Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-09-19
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G22312045620Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-05-23
G22312045660Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
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00817524028157J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028164J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
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00841668135808BAIRD CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135815DESMARRES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07