FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660061296
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Lordan chalazion forceps
Catalog number
2203E
Device description
Lordan chalazion forceps, 3 3/4'', triangular jaws, locking thumb screw, 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
OTC
false
Sterile
false
Single use
false

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
00190660061296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660061296001906600612961906600612960190660061296

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G2231126320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-29
G22312045690Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-01
G223119354A0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-06-17
00840183509040BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
00840183509057BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
00840183516703BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
G22312045620Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-05-23
G22312045660Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
G22312045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
00817524028157J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028164J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028171J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00841668135761ERHARDT LID FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135808BAIRD CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135815DESMARRES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135822FRANCIS CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135839HUNT CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135846LAMBERT CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135853LORDAN CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135860WIES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135877MONTOYA MULLERECTOMY FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07