FDA.report

CEMSTOP INSTRUMENTATION

Primary DI
03760177040243
Brand
CEMSTOP INSTRUMENTATION
Company
TEKNIMED
Model
Restrictor inserter
Catalog number
T067701
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
03760177040243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760177040243037601770402433760177040243

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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

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03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
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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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