FDA.reportPublic FDA data

IRRIGATION BAG SPIKE ASSEMBLY FOR SYNERGY DRILL SYSTEM

Primary DI
00821925020146
Brand
IRRIGATION BAG SPIKE ASSEMBLY FOR SYNERGY DRILL SYSTEM
Company
Gyrus Acmi, Inc.
Model
325505
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
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925020146PackageGS16In Commercial Distribution
00821925040274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925020146008219250201468219250201460821925020146
00821925040274008219250402748219250402740821925040274

GMDN Terms#

Term, Definition table
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 table
Method

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
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
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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Primary DI, Brand, Company table
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04573316385377KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316388538KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
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00849296016964WelmedWELMED INC.GAZ2026-02-15
00849296016971WelmedWELMED INC.GAZ2026-02-15
00849296016988WelmedWELMED INC.GAZ2026-02-15
00849296016995WelmedWELMED INC.GAZ2026-02-15
00849296017008WelmedWELMED INC.GAZ2026-02-15
00849296017015WelmedWELMED INC.GAZ2026-02-15
00849296017022WelmedWELMED INC.GAZ2026-02-15
00849296017039WelmedWELMED INC.GAZ2026-02-15
50885380072350CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10885380172519CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172526CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172533CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172557CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172571CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172595CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
00810130455478Medco Manufacturing IncMedco Manufacturing LLCGAZ2025-09-11