FDA.report

CEMSTOP INSTRUMENTATION

Primary DI
03760177040311
Brand
CEMSTOP INSTRUMENTATION
Company
TEKNIMED
Model
CONTAINER
Catalog number
T067799
Published
2020-09-28
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03760177040311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760177040311037601770403113760177040311

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
764746723
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03701505801020PureKit Syringe 1.5cc MVT060428MV2025-03-31
03701505801037META+ System 1.5cc MVT040352MV2025-03-31
03701505801075PUREKIT SyringesT0604262025-03-31
03701505801082Syringes 4ccT0604272025-03-31
03701505801099Syringes 1.5ccT0604282025-03-31
03760177045361PureKit Gun MVT060425MV2023-03-30
03760177040113OPACITY +T040320ZT040320Z2015-10-16
03760177041110F20T040520T0405202015-10-16
03760177041721HIGH V+T040321T0403212017-08-22
03760177042391EXOFIXT040323T0403232015-10-16

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