FDA.report

7.5 mm Drill

Primary DI
00810097800304
Brand
7.5 mm Drill
Company
SMV SCIENTIFIC LLC
Model
1252-4107
Catalog number
1252-4107
Device description
7.5 mm Drill
Published
2022-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTWBit, Drill
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810097800304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097800304008100978003048100978003040810097800304

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter7.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags

DUNS number
089645059
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
false
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

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008100743000014.0 x 12mm Screw Super Fastener, ST340-2012340-20122023-06-12
008100743000184.0 x 14mm Screw Super Fastener, ST340-2014340-20142023-06-12
008100743000254.0 x 16mm Screw Super Fastener, ST340-2016340-20162023-06-12
008100743000324.0 x 18mm Screw Super Fastener, ST340-2018340-20182023-06-12
008100743000494.0 x 20mm Screw Super Fastener, ST340-2020340-20202023-06-12
008100743000564.0 x 22mm Screw Super Fastener, ST340-2022340-20222023-06-12
008100743000634.0 x 24mm Screw Super Fastener, ST340-2024340-20242023-06-12
008100743000704.0 x 26mm Screw Super Fastener, ST340-2026340-20262023-06-12
008100743000874.0 x 28mm Screw Super Fastener, ST340-2028340-20282023-06-12
008100743000944.0 x 30mm Screw Super Fastener, ST340-2030340-20302023-06-12
008100743001004.0 x 32mm Screw Super Fastener, ST340-2032340-20322023-06-12
008100743001174.0 x 34mm Screw Super Fastener, ST340-2034340-20342023-06-12
008100743001244.0 x 36mm Screw Super Fastener, ST340-2036340-20362023-06-12
008100743001314.0 x 38mm Screw Super Fastener, ST340-2038340-20382023-06-12
008100743001484.0 x 40mm Screw Super Fastener, ST340-2040340-20402023-06-12
008100743001554.0 x 42mm Screw Super Fastener, ST340-2042340-20422023-06-12
008100743001624.0 x 44mm Screw Super Fastener, ST340-2044340-20442023-06-12
008100743001794.0 x 46mm Screw Super Fastener, ST340-2046340-20462023-06-12
008100743001864.0 x 48mm Screw Super Fastener, ST340-2048340-20482023-06-12
008100743001934.0 x 50mm Screw Super Fastener, ST340-2050340-20502023-06-12

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