FDA.report

SYNERGY HANDPIECE

Primary DI
00821925020153
Brand
SYNERGY HANDPIECE
Company
Gyrus Acmi, Inc.
Model
325507
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925020153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925020153008219250201538219250201530821925020153

GMDN Terms

TermDefinition
Middle ear drill bitA cylindrical shaft of metal with a small cutting head (e.g., twisted or helicoidal) which when rotated will bore into the tissues of the middle ear to excavate, perforate, or excise tissue (e.g., ossicles, cartilage) during a middle ear (endaural) surgical procedure. This device is typically mounted into a powered surgical drill system handpiece that provides rotation. It is available in various cutting head sizes/shapes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
007198742
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
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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00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

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