FDA.reportPublic FDA data

LEVEL ONE CMF

Primary DI
00888118032812
Brand
LEVEL ONE CMF
Company
KLS-Martin L.P.
Model
01-379-01-09
Device description
PLATE, MINI, TLTS, L SHP, RIGHT, 2.0-2.5 MM SCREW, CP TITANIUM
Published
2016-03-24
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
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118032812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118032812008881180328128881180328120888118032812

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@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
00888118153746DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153753DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153777DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153784DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153807DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153814DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153838DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153845DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153869DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153876DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153890DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153906DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153920DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153937DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153951DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153968DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
00888118153982DISTRACTION, INTERNALKLS-Martin L.P.MQN2026-05-25
00888118153999DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153767DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153798DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153828DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153859DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153880DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153910DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153941DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118153972DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
10888118154009DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2026-05-25
07613327682717NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
07613327682724NAStryker Leibinger GmbH & Co. KGMQN2026-02-27
00888118145376IPSKLS-Martin L.P.MQN2025-09-24