FDA.reportPublic FDA data

Daniels

Primary DI
09333990004378
Brand
Daniels
Company
DANIELS CORPORATION INTERNATIONAL PTY LTD
Model
4500101001
Device description
Bladesafe, Unsterile
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
09333990004378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09333990004378093339900043789333990004378

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, non-sterileA non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
740491188
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09333990004798Secure-A-Sharp16260000102023-06-28
09333990004811Secure a Sharp16250000112023-06-28
09333990000066Daniels10011075002018-05-02
09333990000073Daniels10011075042018-05-02
09333990000127Daniels10012075002018-05-02
09333990000134Daniels10012075042018-05-02
09333990000189Daniels10013075002018-05-02
09333990000196Daniels10013075042018-05-02
09333990000233Daniels10031035012018-05-02
09333990000271Daniels10032035012018-05-02
09333990000318Daniels10033035012018-05-02
09333990000332Daniels10033075052018-05-02
09333990002879Daniels64031035012018-05-02
09333990004422Daniels10031075052019-03-07
09333990004514Daniels10032075052019-03-07
09333990004538Daniels10012015202018-05-02
09333990004682Daniels64036105082018-05-02
09333990004880Daniels64031075032018-05-02
09333990005016Daniels10011075162019-09-13
09333990005023Daniels10012075162019-09-13

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00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
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