FDA.report

SCREWDRIVER HEX. 3,5 mm

Primary DI
08057968718944
Brand
SCREWDRIVER HEX. 3,5 mm
Company
HPF SRL
Model
9095.10.225
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057968718944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08057968718944080579687189448057968718944

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
895802853
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08055727370914STRAIGHT HANDLE HC CONN. ZIMMER01.11.10.07012022-09-09
08055727370921STRAIGHT HANDLE NEW HC CONN. ZIMMER01.11.10.07212022-09-09
08055727370938STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07002022-09-09
08055727370945STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07202022-09-09
08055727370952STRAIGHT HANDLE HC CONN. HUDSON01.11.10.07022022-09-09
08055727370969STRAIGHT HANDLE NEW HC CONN. HUDSON01.11.10.07222022-09-09
08055727371850STRAIGHT HANDLE UNIVERSAL CONN. ZIMMER01.11.10.07112022-09-09
08055727371867STRAIGHT HANDLE UNIVERSAL CONN. A.O.01.11.10.07102022-09-09
08055727371874STRAIGHT HANDLE UNIVERSAL CONN. HUDSON01.11.10.07122022-09-09
08055727372260THIN OSTEOTOME BLADE 76x8 WITH HOLE903000658002022-09-09
08055727372277THIN OSTEOTOME BLADE 76x10 WITH HOLE903000658102022-09-09
08055727372284THIN OSTEOTOME BLADE 76x12 WITH HOLE903000658202022-09-09
08055727372291THIN OSTEOTOME BLADE 76x20 WITH HOLE903000658302022-09-09
08055727372413THIN OSTEOTOME BLADE 127x8 WITH HOLE903000659502022-09-09
08055727372420THIN OSTEOTOME BLADE 127x10 WITH HOLE903000659602022-09-09
08055727372529THIN OSTEOTOME BLADE 76x8 WITH SLOT01.10.10.20552022-09-09
08055727372536THIN OSTEOTOME BLADE 76x10 WITH SLOT01.10.10.20562022-09-09
08055727372543THIN OSTEOTOME BLADE 76x12 WITH SLOT01.10.10.20572022-09-09
08055727372550THIN OSTEOTOME BLADE 76x20 WITH SLOT01.10.10.20582022-09-09
08055727372567THIN OSTEOTOME BLADE 127x8 WITH SLOT01.10.10.20592022-09-09

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