FDA.reportPublic FDA data

Dental

Primary DI
05055382844396
Brand
Dental
Company
TIMESCO HEALTHCARE LIMITED
Model
740.650.35
Catalog number
740.650.35
Device description
"Mead Bone Rongeur No: 1a, 6.5"" Plain"
Published
2023-07-06
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
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055382844396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055382844396050553828443965055382844396

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It 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
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
00840183532413BR Surgical, LLCBR Surgical, LLCEGN2026-07-17
B382SD9074751070Surgical DirectSurgical Direct, Inc.EGN2026-07-17
B382SD9084541040Surgical DirectSurgical Direct, Inc.EGN2026-07-17
B382SD903988102SC0Surgical DirectSurgical Direct, Inc.EGN2026-07-14
B382SD9039991090Surgical DirectSurgical Direct, Inc.EGN2026-07-14
00841013124716MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.EGN2026-06-26
B382S37841020Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37842000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37935000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903070100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903071100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD90315118T0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9034541060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035521000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035651000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037861000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037871010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903797030Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903870060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039790010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039871000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
08961104625839MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625846MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22