FDA.report

MICA

Primary DI
00889797056717
Brand
MICA
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
57S02025
Catalog number
57S02025
Device description
Hex Driver
Published
2018-01-29
Public version status
Update
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

Contact Domains

Product Codes

CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications

CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797056717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797056717008897970567178897970567170889797056717

GMDN Terms

TermDefinition
Surgical screwdriver, single-use, sterileA sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

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00888867500877Arthrex®ARTHREX, INC.HWR2026-03-13
10705034579085N/AMedos International SàrlHWR2026-03-05
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0088902470557940mm Head PusherZimmer, Inc.HWR2026-01-16
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00840180543535General InstrumentsALPHATEC SPINE, INC.HWR2025-12-31
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04719886910902USTAR II Knee SystemUNITED ORTHOPEDIC CORP.HWR2025-11-13
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07640332476307SCARLET AL-T INSTRUMENTATIONSpineArt SAHWR2025-11-11
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00190376662213IdentiTi IIALPHATEC SPINE, INC.HWR2025-09-05
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