FDA.reportPublic FDA data

Surgical

Primary DI
05055382833055
Brand
Surgical
Company
TIMESCO HEALTHCARE LIMITED
Model
40.905.10
Device description
"Jansen Rongeur Cur 4mmx6""(15.5cm)"
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055382833055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055382833055050553828330555055382833055

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutting forceps, reusableA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.

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
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
05055382843498Dental640.425.25640.425.252023-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840642182149Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182156Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182163Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21