FDA.reportPublic FDA data

Walcott Rx

Primary DI
00841019109908
Brand
Walcott Rx
Company
Walcott Rx Product Inc
Model
RX14-5007
Device description
Bipolar Pencil 23 Gauge
Published
2016-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864402000BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBENew England Surgical Instrument Corp.1987-01-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019109905PackageGS15In Commercial Distribution
20841019109902PackageGS125In Commercial Distribution
00841019109908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101910990510841019109905
2084101910990220841019109902
00841019109908008410191099088410191099080841019109908

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500kprario@ksp.com
781-834-9500mprario@ksp.com

Regulatory Flags#

DUNS number
837689694
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840285320796Walcott Rx ProductsRx0-375-23-132026-06-26
00840285320789Walcott Rx ProductsRx2-0762026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16