FDA.reportPublic FDA data

Sterilization Tray

Primary DI
00846338002626
Brand
Sterilization Tray
Company
ELLIQUENCE, LLC
Model
14-2000
Published
2025-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338002626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338002626008463380026268463380026260846338002626

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
019872358
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338002688Motor16-01052025-01-10
00846338005566Retractor15-23212025-01-10
00846338005573Retractor15-23222025-01-10
00846338005634Bone Curette15-25322025-01-10
00846338005641Bone Curette15-25332025-01-10
00846338005658Bone Curette15-25342025-01-10
00846338005665Bone Curette15-25352025-01-10
00846338005672Bone Curette15-25362025-01-10
00846338005733Cup Forceps15-16412025-01-10
00846338005740Cup Forceps15-16422025-01-10
00846338005795Kerrison15-19242025-01-10
00846338005863Kerrison15-19342025-01-10
00846338005917Kerrison15-19392025-01-10
00846338000738ForcepsDFX-G2025-01-09
00846338001391ForcepsDFX-GS2025-01-09
00846338001513Access Needle (16 Gauge)N6-D4/12025-01-09
00846338001650Surgi-Max® Ultra - FootswitchBF-FSCB#2025-01-09
00846338001667Surgi-Max® Ultra - FootswitchTF-FSCB#2025-01-09
00846338002183Dissector11-24112025-01-09
00846338002190Probe11-24152025-01-09

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