FDA.reportPublic FDA data

Post Drill Guide Sleeve, 28mm

Primary DI
00816101010394
Brand
Post Drill Guide Sleeve, 28mm
Company
TOBY ORTHOPAEDICS
Model
NA
Catalog number
TO-PH-PDGS-28
Device description
Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies with a handle, and others are threaded to screw into plates.
Published
2020-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816101010394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816101010394008161010103948161010103940816101010394

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
305-665-8699sales@tobyortho.com

Regulatory Flags#

DUNS number
024163331
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorNATO-FTRT2026-04-22
00816101017973Cannulated Cruciform Driver with Quick ConnectNATO-DRI-CQCCR2026-04-21
00816101011933WOLF Plate, 70mm, 5 HoleNATO-LBP-0702020-08-15
00816101011940WOLF Plate, 96mm, 7 HoleNATO-LBP-0962020-08-15
00816101011957WOLF Plate, 122mm, 9 HoleNATO-LBP-1222020-08-15
00816101011964WOLF Plate, 148mm, 11 HoleNATO-LBP-1482020-08-15
00816101011971WOLF Plate, 174mm, 13 HoleNATO-LBP-1742020-08-15
00816101011988WOLF Plate, 200mm, 15 HoleNATO-LBP-2002020-08-15
00816101011995WOLF Plate, 226mm, 17 HoleNATO-LBP-2262020-08-15
00816101012008WOLF Plate, 252mm, 19 HoleNATO-LBP-2522020-08-15
00816101012015WOLF Plate, 278mm, 21 HoleNATO-LBP-2782020-08-15
00816101012022WOLF Low Profile Plate, 70mm, 5 HoleNATO-LP-LBP-0702020-08-15
00816101012039WOLF Low Profile Plate, 96mm, 7 HoleNATO-LP-LBP-0962020-08-15
00816101012046WOLF Low Profile Plate, 122mm, 9 HoleNATO-LP-LBP-1222020-08-15
00816101012053WOLF Low Profile Plate, 148mm, 11 HoleNATO-LP-LBP-1482020-08-15
00816101012060WOLF Curved Low Profile Plate, 174mm, 13 HoleNATO-CLP-LBP-1742020-08-15
00816101012077WOLF Curved Low Profile Plate, 200mm, 15 HoleNATO-CLP-LBP-2002020-08-15
00816101012084WOLF Curved Low Profile Plate, 226mm, 17 HoleNATO-CLP-LBP-2012020-08-15
00816101010257PANTERA PLATE, LEFT, 73mmNATO-PHP-L732020-08-13
00816101010264PANTERA PLATE, RIGHT, 73mmNATO-PHP-R732020-08-13

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Primary DI, Brand, Company table
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