FDA.report

Wexler Surgical, Inc.

Primary DI
M944AL005710
Brand
Wexler Surgical, Inc.
Company
WEXLER SURGICAL, INC.
Model
AL0057.1
Published
2018-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNZCurette, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M944AL005710PrimaryHIBCC0
00840240905822SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840240905822008402409058228402409058220840240905822

GMDN Terms

TermDefinition
Lens spoonA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
024882552
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 DIBrandModelCatalogPublished
00840240938202Wexler Surgical, Inc.SA-C-RB3L2025-08-22
00840240938219Wexler Surgical, Inc.SA-C-RB4L2025-08-22
00840240938226Wexler Surgical, Inc.SA-C-RB52025-08-22
00840240938127Wexler Surgical, Inc.SA-RB32025-05-16
00840240938110Wexler Surgical, Inc.SA-RB42025-05-16
00840240938103Wexler Surgical, Inc.SA-RB52025-05-16
00840240938097Wexler Surgical, Inc.SA-RB62025-05-16
00840240938066Wexler Surgical, Inc.LA-FM32025-03-28
00840240938073Wexler Surgical, Inc.LA-FM3U2025-03-28
00840240938059Wexler Surgical, Inc.MA-FM32025-03-28
00840240937786Wexler Surgical, Inc.SA-CB15L2025-03-28
00840240937793Wexler Surgical, Inc.SA-CB1L2025-03-28
00840240937809Wexler Surgical, Inc.SA-CB25L2025-03-28
00840240937816Wexler Surgical, Inc.SA-CB2L2025-03-28
00840240938035Wexler Surgical, Inc.SA-CB32025-03-28
00840240937823Wexler Surgical, Inc.SA-CB35L2025-03-28
00840240937830Wexler Surgical, Inc.SA-CB3L2025-03-28
00840240937847Wexler Surgical, Inc.SA-CB42025-03-28
00840240937854Wexler Surgical, Inc.SA-CB52025-03-28
00840240937861Wexler Surgical, Inc.SA-CB62025-03-28

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