FDA.reportPublic FDA data

LEVEL ONE CMF

Primary DI
00888118113016
Brand
LEVEL ONE CMF
Company
KLS-Martin L.P.
Model
50-174-03-61
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEIProsthesis, condyle, mandibular, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEIProsthesis, Condyle, Mandibular, TemporaryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118113016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118113016008881181130168881181130160888118113016

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746webcontact@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
DM exempt
false
Premarket exempt
false
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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
37613327572088Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
07613327572087Universal Mandible AXSStryker Leibinger GmbH & Co. KGNEI2023-09-15
10888118131260LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131249LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131256LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118131263LEVEL ONE CMFKLS-Martin L.P.NEI2021-11-22
00888118073471LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073488LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073501LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073518LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073532LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00888118073570LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073492LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
10888118073553LEVEL ONE CMFKLS-Martin L.P.NEI2016-03-24
00841036009830"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
00841036009847"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
00841036091507"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INCNEI2015-10-11
34546540373985NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
04546540373991NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
04546540374004NAStryker Leibinger GmbH & Co. KGNEI2015-09-24
10887587016382NASynthes GmbHNEI2015-09-14
10887587016399NASynthes GmbHNEI2015-09-14
10887587016405NASynthes GmbHNEI2015-09-14
10887587016412NASynthes GmbHNEI2015-09-14
10887587016429NASynthes GmbHNEI2015-09-14
10887587016436NASynthes GmbHNEI2015-09-14
10887587016443MatrixMANDIBLESynthes GmbHNEI2015-09-14
10887587054537NASynthes GmbHNEI2015-09-14
10887587054544NASynthes GmbHNEI2015-09-14
10887587054551NASynthes GmbHNEI2015-09-14