FDA.report

Newclip Instruments

Primary DI
03700569637132
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
33.0216.100-ST
Catalog number
33.0216.100-ST
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700569637132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700569637132037005696371323700569637132

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
263281904
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03700569660000KEMISANC2092025-12-10
03700569660017KEMISANC11032025-12-10
0340042000005006082025GUDIDSync2.00106082025GUDIDSync22025-08-14
0340042000002915072025GUDIDSync115072025GUDIDSync12025-08-12
03700569604233Alians ClavicleQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257Alians ClavicleQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271Alians ClavicleQOT3.5L14-STQOT3.5L14-ST2024-11-15
03700569604295Alians ClavicleQOT3.5L16-STQOT3.5L16-ST2024-11-15
03700569604318Alians ClavicleQOT3.5L18-STQOT3.5L18-ST2024-11-15
03700569604332Alians ClavicleQOT3.5L20-STQOT3.5L20-ST2024-11-15
03700569604356Alians ClavicleQOT3.5L22-STQOT3.5L22-ST2024-11-15
03700569604370Alians ClavicleQOT3.5L24-STQOT3.5L24-ST2024-11-15
03700569604394Alians ElbowQOT3.5L26-STQOT3.5L26-ST2024-11-15
03700569604400Alians ElbowQOT3.5L28QOT3.5L282024-11-15
03700569604417Alians ElbowQOT3.5L28-STQOT3.5L28-ST2024-11-15
03700569604424Alians ElbowQOT3.5L30QOT3.5L302024-11-15
03700569604431Alians ElbowQOT3.5L30-STQOT3.5L30-ST2024-11-15
03700569604448Alians ElbowQOT3.5L32QOT3.5L322024-11-15
03700569604455Alians ElbowQOT3.5L32-STQOT3.5L32-ST2024-11-15
03700569604462Alians ElbowQOT3.5L34QOT3.5L342024-11-15

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