FDA.reportPublic FDA data

Walcott Rx Products

Primary DI
00840285320789
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx2-076
Device description
Suturing Forcep
Published
2026-06-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840285320789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285320789008402853207898402853207890840285320789

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical device handling forceps, reusableA hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. 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(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
false
Serial number
true
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
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
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D5052200TENNAT TYING FORCEPS STR DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052300TENNAT TYING FORCEPS CVD DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052340MAUMENEE TYING FORCEPS STRDAUD JEE MFG. COHNR2023-01-05
G006D5052350MAUMENEE TYING FORCEPS ANGDAUD JEE MFG. COHNR2023-01-05
G006D5054000HARMS TYING FORCEPS STR STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5054100HARMS TYING FORCEPS CVD STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5051120ANIS TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-21
G006D5051130ANIS TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-21
G006D5051900FREEMAN-JAFFE LENS HOLDING FORCEPSDAUD JEE MFG. COHNR2022-12-21
G006D5052000JAFFE TYING FORCEPS STRAIGHT DAUD JEE MFG. COHNR2022-12-21
G006D5052100JAFFE TYING FORCEPS CURVED DAUD JEE MFG. COHNR2022-12-21
G006D5051000SINSKEY TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-20
G006D5051100SINSKEY TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-20
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50313000Capsulorhexis Forceps G PATTERNDAUD JEE MFG. COHNR2022-12-19
G006D504050810 CAPS FORCEPS RND HDL STR DAUD JEE MFG. COHNR2022-12-19
G006D505000910CAPSULORRHEXIS FORCEPS ROUND HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D505000990CAPSULORRHEXIS FORCEPS FOR MICRO COXIAL 2MMDAUD JEE MFG. COHNR2022-12-19
G006D506000000CAPSULORRHEXIS FORCEPS FOR MICS/MCCSDAUD JEE MFG. COHNR2022-12-19
G006D506000020CAPSULORRHEXIS FORCEPS 12MMDAUD JEE MFG. COHNR2022-12-19
G006D506000030CAPSULORRHEXIS FORCEPS 11MMDAUD JEE MFG. COHNR2022-12-19
G006D5060000510PRECHOPPER COMBO CROSS SECTION SHARP TIPDAUD JEE MFG. COHNR2022-12-19
G006D507000030CAPSULORRHEXIS FORCEPS 11MM ANGLEDDAUD JEE MFG. COHNR2022-12-19
G006D50800012340TITANIUM CAPSULORRHEXIS FORCEPS ERGONOMIC HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D508000123410TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 12MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123420TITANIUM CAPSULORRHEXIS FORCEPS ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123430TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17