FDA.reportPublic FDA data

Tools - CFF

Primary DI
00842188110641
Brand
Tools - CFF
Company
TRIMED, INCORPORATED
Model
SPIN-5.0/230
Catalog number
SPIN-5.0/230
Device description
Steinmann Pin 5.0, 230mm
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188110641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188110641008421881106418421881106410842188110641

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
DM exempt
true
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188126741Foot PlatesCSOP6-6CSOP6-62024-04-24
00842188127632Foot PlatesCSOP8-6CSOP8-62024-04-24
00842188127649Foot PlatesCSOP10-6CSOP10-62024-04-24
00842188127656Foot PlatesEOP-4EOP-42024-04-24
00842188127663Foot PlatesEOP-4SEOP-4S2024-04-24
00842188127670Foot PlatesHP-4HP-42024-04-24
00842188127687Foot PlatesHP-4LHP-4L2024-04-24
00842188127694Foot PlatesHP-4SHP-4S2024-04-24
00842188127700Foot PlatesTN-7TN-72024-04-24
00842188127717Foot PlatesTN-7LTN-7L2024-04-24
00842188127724Foot PlatesTN-7STN-7S2024-04-24
00842188127731Foot PlatesMCFL-12MCFL-122024-04-24
00842188127748Foot PlatesMCFL-12LMCFL-12L2024-04-24
00842188127755Foot PlatesMCFR-12MCFR-122024-04-24
00842188127762Foot PlatesMCFR-12LMCFR-12L2024-04-24
00842188127779Foot PlatesMCFL-17MCFL-172024-04-24
00842188127786Foot PlatesMCFL-17LMCFL-17L2024-04-24
00842188127793Foot PlatesMCFR-17MCFR-172024-04-24
00842188127809Foot PlatesMCFR-17LMCFR-17L2024-04-24
00842188127915Foot PlatesMOPL-4LMOPL-4L2024-04-24

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Primary DI, Brand, Company table
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00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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