FDA.reportPublic FDA data

HDC

Primary DI
08057013140102
Brand
HDC
Company
H.D.C. SRL
Model
DLM-3134
Catalog number
DLM-3134
Device description
Contra angle driver TAD key
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091390000HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2Hdc S.R.L.2009-07-30OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057013140102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057013140102080570131401028057013140102

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
339583417
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057013140447SPIDER SCREWSCL-1308SCL-13082016-08-24
08057013140454SPIDER SCREWSCL-1310SCL-13102016-08-24
08057013140461SPIDER SCREWSCL-1506SCL-15062016-08-24
08057013140478SPIDER SCREWSCL-1508SCL-15082016-08-24
08057013140485SPIDER SCREWSCL-1510SCL-15102016-08-24
08057013140508SPIDER SCREWSCL-1906SCL-19062016-08-24
08057013140515SPIDER SCREWSCL-1907SCL-19072016-08-24
08057013140522SPIDER SCREWSCL-1909SCL-19092016-08-24
08057013140539SPIDER SCREWSCL-1911SCL-19112016-08-24
08057013140546SPIDER SCREWSCR-1506SCR-15062016-08-24
08057013140553SPIDER SCREWSCR-1508SCR-15082016-08-24
08057013140560SPIDER SCREWSCR-1510SCR-15102016-08-24
08057013140584SPIDER SCREWSCR-1906SCR-19062016-08-24
08057013140591SPIDER SCREWSCR-1907SCR-19072016-08-24
08057013140607SPIDER SCREWSCR-1909SCR-19092016-08-24
08057013140614SPIDER SCREWSCR-1911SCR-19112016-08-24
08057013140645SPIDER SCREWSLP-1506SLP-15062016-08-24
08057013140652SPIDER SCREWSLP-1508SLP-15082016-08-24
08057013140669SPIDER SCREWSLP-1510SLP-15102016-08-24
08057013140676SPIDER SCREWSSM-1506SSM-15062016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15
00841731146823TITANEX VILEX LLCLRZ2026-05-15
00841731146830TITANEX VILEX LLCLRZ2026-05-15
00841731146847TITANEX VILEX LLCLRZ2026-05-15
00841731152237DYNEX VILEX LLCLRZ2026-05-15
00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163094Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176742Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176759Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176766Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176773Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28