FDA.reportPublic FDA data

Surgical

Primary DI
05055382811688
Brand
Surgical
Company
TIMESCO HEALTHCARE LIMITED
Model
14.470.20
Device description
"Spencer Wells Artery Forceps Str 7""(18cm)BJ"
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055382811688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055382811688050553828116885055382811688

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
+441268297700info@timesco.com

Regulatory Flags#

DUNS number
896967197
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055382830467Surgical40.390.202023-06-20
05055382830474Surgical40.390.402023-06-20
05055382833055Surgical40.905.102023-06-20
05055382857662Single Use TourniquetsD80.1002023-09-26
05055382857679Single Use TourniquetsD80.2002023-09-26
05055382858263Single Use TourniquetsD80.1502023-09-26
15055382857669Single Use TourniquetsD80.1002023-09-26
15055382857676Single Use TourniquetsD80.2002023-09-26
15055382858260Single Use TourniquetsD80.1502023-09-26
05055382837596Dental530.700.25530.700.252023-07-11
05055382841234Dental575.200.25575.200.252023-07-11
05055382841258Dental575.225.25575.225.252023-07-11
05055382843115Dental625.500.25625.500.252023-07-11
05055382843344Dental635.600.25635.600.252023-07-11
05055382843368Dental640.325.25640.325.252023-07-11
05055382843382Dental640.325.50640.325.502023-07-11
05055382843429Dental640.335.50640.335.502023-07-11
05055382843443Dental640.340.25640.340.252023-07-11
05055382843450Dental640.350.25640.350.252023-07-11
05055382843474Dental640.400.25640.400.252023-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
B382SD9013461020Surgical DirectSurgical Direct, Inc.GEN2026-07-17
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22