FDA.reportPublic FDA data

PINABALL

Primary DI
57613154881876
Brand
PINABALL
Company
Stryker Leibinger GmbH & Co. KG
Model
6003-003-090
Catalog number
6003-003-090
Device description
PINABALL PRELOADED PINS
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
57613154881876PackageGS15In Commercial Distribution
37613154881872PrimaryGS10
07613154881871Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761315488187657613154881876
3761315488187237613154881872
07613154881871076131548818717613154881871

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
Length90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
4
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327682717NA92-0232592-023252026-02-27
07613327682724NA92-0232492-023242026-02-27
37613327090810NA92-1710592-171052015-09-24
37613327090827NA92-1710492-171042015-09-24
37613327090834NA92-1710692-171062015-09-24
37613327090841NA92-1710892-171082015-09-24
37613327090858NA92-8170392-817032015-09-24
37613327090865NA92-8170492-817042015-09-24
37613327090872NA92-8170592-817052015-09-24
37613327090889NA92-8170692-817062015-09-24
37613327090902NA92-8170892-817082015-09-24
37613327090919NA92-8171092-817102015-09-24
37613327090926NA92-8171292-817122015-09-24
37613327090940NA92-8190592-819052015-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327680522NA92-5553192-555312025-07-31
07613327651461NA92-0551292-055122025-07-09
07613327504385NA92-0233392-023332020-05-12
07613327504392NA92-0233292-023322020-05-12
07613327353563NA6002-140-2006002-140-2002025-02-19

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Primary DI, Brand, Company table
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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