FDA.reportPublic FDA data

MULTI-GUIDE

Primary DI
34546540259067
Brand
MULTI-GUIDE
Company
Stryker Leibinger GmbH & Co. KG
Model
62-20022
Catalog number
62-20022
Device description
SELF-DRILLING PINS, AUTO PILOT
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960297000MANDIBULAR BONE DISTRACTOR IIHowmedica Corp.1996-08-06MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540259067PrimaryGS10
04546540259066Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654025906734546540259067
04546540259066045465402590664546540259066

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length10Millimeter
Length90Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
2
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23
07613327500622N/A8000-060-0148000-060-0142023-03-23
07613327500639N/A8000-060-0158000-060-0152023-03-23
07613327500646N/A8000-060-0188000-060-0182023-03-23
07613327538328Cranial Guidance Software81-8104281-810422023-03-23
07613327538410Cranial Guidance Software6000-670-3006000-670-3002023-03-23
07613327500509N/A8000-040-0178000-040-0172023-03-22
07613327500523N/A8000-040-0188000-040-0182023-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118006189LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006202LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006226LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007261LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007278LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118032812LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037480LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037503LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037510LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039439LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039446LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044457LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044471LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044495LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044518LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044532LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044556LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044631LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044655LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044679LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045010LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045034LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045058LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045072LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045096LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045119LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045133LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045195LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045485LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24