FDA.report

GOEZ SCREW 6.5 X 105MM

Primary DI
00810012482363
Brand
GOEZ SCREW 6.5 X 105MM
Company
BIOPRO, INC.
Model
19669
Published
2019-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810012482363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012482363008100124823638100124823630810012482363

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods

Method

Regulatory Flags

DUNS number
618749857
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20923217MTP Targeting Guide Assembly232172025-11-28
M20923227Modular Thumb Rasp Serrated 7.5MM232272025-11-28
M20923228Modular Thumb Rasp Serrated 8.5MM232282025-11-28
M20923229Modular Thumb Rasp Serrated 10.0MM232292025-11-28
M20923230Modular Thumb Rasp Serrated 11.5MM232302025-11-28
M209177990THUMB MOD HEAD TITANIUM 13MM+2177992024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MM177802024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2178012024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MM178062024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2178072024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MM178082024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2178092024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MM177982024-05-30
M209230790MTP FUSION PLATE 5 DEGREE, LEFT230792024-03-26
M209230800MTP FUSION PLATE 5 DEGREE, RIGHT230802024-03-26
M209230810MTP FUSION PLATE 0 DEGREE, LEFT230812024-03-26
M209230820MTP FUSION PLATE 0 DEGREE, RIGHT230822024-03-26
M209230830MTP FUSION PLATE, NARROW 10 DEGREE, LEFT230832024-03-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10