FDA.reportPublic FDA data

Walcott Rx Products

Primary DI
00840285319592
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx704
Device description
Diamond Knife
Published
2022-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNNKnife, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840285319592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285319592008402853195928402853195920840285319592

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)837-9875sales@walcottrx.com

Regulatory Flags#

DUNS number
837689694
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840285306899Walcott Rx ProductsRx4-0002022-08-10
00840285306905Walcott Rx ProductsRx4-000T2022-08-10
00840285306912Walcott Rx ProductsRx4-0012022-08-10
00840285306929Walcott Rx ProductsRx4-001T2022-08-10
00840285306936Walcott Rx ProductsRx4-0022022-08-10
00840285306943Walcott Rx ProductsRx4-0052022-08-10
00840285306950Walcott Rx ProductsRx4-005T2022-08-10
00840285306967Walcott Rx ProductsRx4-0062022-08-10
00840285306974Walcott Rx ProductsRx4-006T2022-08-10
00840285306981Walcott Rx ProductsRx4-0082022-08-10
00840285306998Walcott Rx ProductsRx4-0092022-08-10
00840285307001Walcott Rx ProductsRx4-009T2022-08-10
00840285307018Walcott Rx ProductsRx402S2022-08-10
00840285307025Walcott Rx ProductsRx4022022-08-10
00840285307032Walcott Rx ProductsRx4-0112022-08-10
00840285307049Walcott Rx ProductsRx4-011T2022-08-10
00840285307056Walcott Rx ProductsRx402SM2022-08-10
00840285307063Walcott Rx ProductsRx401S2022-08-10
00840285307070Walcott Rx ProductsRx401RS2022-08-10
00840285307087Walcott Rx ProductsRx401R2022-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033802Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033819Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033826Scleral Knife Angled AKTIVE SRLHNN2024-01-17
08052276033833Stab Knife 15° AKTIVE SRLHNN2024-01-17
08052276033840Stab Knife 15° with protectionAKTIVE SRLHNN2024-01-17
08052276033857Stab Knife 22,5°AKTIVE SRLHNN2024-01-17
08052276033864Stab Knife 22,5° with protectionAKTIVE SRLHNN2024-01-17
08052276033871Stab Knife 30° AKTIVE SRLHNN2024-01-17
08052276033888Stab Knife 30° with protectionAKTIVE SRLHNN2024-01-17
08052276033895Stab Knife 45° AKTIVE SRLHNN2024-01-17
08052276033901Stab Knife 45° with protectionAKTIVE SRLHNN2024-01-17
08052276033918Blunt tip Knife 4.0 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033925Blunt tip Knife 4.0 mm Angled Bevel Up with protectionAKTIVE SRLHNN2024-01-17