FDA.reportPublic FDA data

Bioplate®

Primary DI
M384ASHA220
Brand
Bioplate®
Company
Bioplate, Inc.
Model
ASHA-22
Catalog number
ASHA-22
Device description
Screwdriver - 1.5 mm diam., Handle A
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M384ASHA220PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-246-7528INFO@bioplate.com

Regulatory Flags#

DUNS number
838734093
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
M3848157370Bioplate®81-573781-57372026-02-09
M3848157380Bioplate®81-573881-57382026-02-09
M3848157390Bioplate®81-573981-57392026-02-09
M3848120220Bioplate®81-202281-20222018-10-22
M3848135680Bioplate®81-356881-35682018-10-23
M384813568CP0Bioplate®81-3568-CP81-3568-CP2019-02-25
M384ABP2100Bioplate®ABP2-10ABP2-102018-10-23
M384ABP2300Bioplate®ABP2-30ABP2-302018-10-23
M384ABP4300Bioplate®ABP4-30ABP4-302018-10-23
M384AMB3300Bioplate®AMB3-30AMB3-302018-10-29
M384ABP230SALE0Bioplate®ABP2-30-SALEABP2-30-SALE2019-10-15
M384ABP430SALE0Bioplate®ABP4-30-SALEABP4-30-SALE2019-10-15
M3848120930Bioplate®81-209381-20932015-12-03
M3848135730Bioplate®81-357381-35732015-12-03
M384813573US0Bioplate®81-3573[US]81-3573[US]2016-05-27
M3848135740Bioplate®81-357481-35742015-12-03
M3848135750Bioplate®81-357581-35752015-12-03
M3848135780Bioplate®81-357881-35782015-12-03
M3848135790Bioplate®81-357981-35792015-12-03
M3848135800Bioplate®81-358081-35802015-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
00196449017348A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017379A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017386A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017393A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017454A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
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04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056471CEA Thin Needle Holder 170 mmMIZUHO CORPORATIONHAO2026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cmMIZUHO CORPORATIONHAO2026-05-29
04946329058987Micro Scissors 130 mm, FHMIZUHO CORPORATIONHAO2026-05-29
04946329077476Pediatric Mosquito Applier without Hook StrMIZUHO CORPORATIONHAO2026-05-29
04946329077582Bulldog Clamp 82 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077599Bulldog Clamp 67 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077605Bulldog Clamp 54 mm, L-Shaped.MIZUHO CORPORATIONHAO2026-05-29
04946329077612Bulldog Clamp 67 mm, L Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329077629Bulldog Clamp 57 mm, S Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329150216Micro Scissors Streamline S, 175 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150223Micro Scissors Streamline S, 175 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150230Micro Scissors Streamline M, 190 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150247Micro Scissors Streamline M, 190 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150254Micro Scissors Streamline L, 220 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29