FDA.report

SCHUKNECHT HOOK UP .40 MM TIP LENGTH STAINLESS STEEL EBONY FINISH

Primary DI
00821925013001
Brand
SCHUKNECHT HOOK UP .40 MM TIP LENGTH STAINLESS STEEL EBONY FINISH
Company
Gyrus Acmi, Inc.
Model
130201
Published
2018-09-10
Public version status
New
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925013001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925013001008219250130018219250130010821925013001

GMDN Terms

TermDefinition
Surgical instrument container systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable surgical instruments between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers for the transportation of sterile surgical instruments from the central sterilization station to the operating room, and the reverse for soiled instruments to be decontaminated and sterilized; the soiled-instrument containers frequently including pre-soaking capabilities. Smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. 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

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