FDA.report

Walcott Rx Products

Primary DI
00840285317550
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx2-2430
Device description
Capsulorhexis Forcep
Published
2022-08-10
Public version status
New
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

Contact Domains

Product Codes

CodeName
HNRForceps, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840285317550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285317550008402853175508402853175500840285317550

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
+1(800)837-9875sales@walcottrx.com

Regulatory Flags

DUNS number
837689694
Device count
1
DM exempt
true
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
00840285320772Walcott Rx ProductsRx0-037-122025-03-28
00840285320765Walcott Rx ProductsRx4272024-11-22
00840285320758Walcott Rx ProductsRx302024-07-08
00840285320741Walcott Rx ProductsRx4-642T2024-06-24
00840285320734Walcott Rx ProductsRx901-5.752024-06-11
00840285320727Walcott Rx ProductsRx441FL2024-04-08
00840285320710Walcott Rx ProductsRx0-015-102024-03-25
00840285320697Walcott Rx ProductsRx902-8.52024-01-11
00840285320703Walcott Rx ProductsRx902-8.752024-01-11
00840285320680Walcott Rx ProductsRx0-2612023-09-22
00840285320673Walcott Rx ProductsRx4-242T2023-05-16
00840285320666Walcott Rx ProductsRx410S2023-05-09
00840285320659Walcott Rx ProductsRx4-2382023-04-03
00840285320642Walcott Rx ProductsRx0-2072023-03-24
00840285320543Walcott Rx ProductsRx3822022-12-07
00840285320550Walcott Rx ProductsRx3832022-12-07
00840285320567Walcott Rx ProductsRx0-10002022-12-07
00840285320574Walcott Rx ProductsRx418T2022-12-07
00840285320529Walcott Rx ProductsRx2692022-12-05
00840285320536Walcott Rx ProductsRx2692022-12-05

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G04320068G0GEIZBear-Ent, LLCHNR2026-05-26
00041533986522Bruder KarpeckiThe Hilsinger Company Parent, LlcHNR2026-05-22
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04251047910357Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047911675Utrata Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047913990Kelman-McPherson Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
04251047918261Castroviejo Needle HolderA1 Medical GmbHHNR2026-05-22
04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047925399Ergo Grip Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
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04251047931581Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
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04251047933165SIGNUM LEHNER MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933189SIGNUM INAMURA MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047934407Alio MICS Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047934711Gerten DMEK Rhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047936418Gerten Iridectomy ForcepsA1 Medical GmbHHNR2026-05-22
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