FDA.report

Bruder Karpecki

Primary DI
00041533986522
Brand
Bruder Karpecki
Company
The Hilsinger Company Parent, Llc
Model
98652
Catalog number
1301487
Device description
KARPECKI BANDAGE LENS FORCEPS
Published
2026-05-22
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

Related Records

Contact Domains

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00041533986522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00041533986522000415339865220415339865220041533986522

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8009556544qara@hilcovision.com

Regulatory Flags

DUNS number
118449190
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
00041533986119Bruder9861110942312026-02-25
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00041533986300Bruder Livengood9863010729942026-02-25
00041533986508Bruder9865010839302026-02-25
00041533986515Bruder Karpecki9865113014602026-02-25
00041533986539Bruder Karpecki9865313094372026-02-25
00041533986546Bruder Karpecki9865413014632026-02-25
00041533986577Bruder Karpecki9865713014672026-02-25
00041533986584Bruder9865813014612026-02-25
00041533987031Bruder9870313014622026-02-25
00041533987048Bruder 9870413014742026-02-25
00041533987079Bruder9870713014852026-02-25
00041533996538Bruder Karpecki9965310942322026-02-25

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